Devices for minimally invasive pelvic surgery

ABSTRACT

The invention, in various embodiments, provides systems, devices, and methods for treating urinary incontinence. 
     The present invention relates to prefabricated urethral suspension slings, methods of making the slings, methods of attaching suture to the slings, kits comprising the slings, and methods of using the slings to treat urinary incontinence. The slings comprise a biocompatible material having an elongate shape adapted for urethral suspension. The material has a central portion extending longitudinally between a first end portion and a second end portion. Each end portion of the sling contains at least one suture receiving site. The suture receiving sites are formed prior to surgery and may be reinforced through a variety of means. Sutures may be attached to the suture receiving sites during the manufacturing process or by the physician prior to or during surgery. Additionally, the end portions of the sling containing the suture receiving sites may be thicker than the central portion of the sling.

RELATED APPLICATIONS

This application is a continuation of prior application Ser. No.10/939,191, filed Sep. 10, 2004, which is a continuation of priorapplication Ser. No. 10/774,826, filed Feb. 9, 2004, and priorapplication Ser. No. 10/774,842, filed Feb. 9, 2004, both of which arecontinuations of application Ser. No. 10/015,114, filed Nov. 12, 2001,now U.S. Pat. No. 6,752,814, which is a continuation of application Ser.No. 09/023,965, filed Feb. 13, 1998, now U.S. Pat. No. 6,423,080, whichclaims the benefit of and priority to U.S. Provisional PatentApplication Ser. No. 60/038,171, filed Feb. 13, 1997, all of which arehereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

Part A

The present invention relates to devices and methods for treatingincontinence.

Part B

The present invention relates to slings for use in improving urinarycontinence. More particularly, the present invention relates toprefabricated urethral stabilization or suspension slings, methods ofmaking the slings and kits including the slings.

BACKGROUND OF THE INVENTION

Part A

Urinary incontinence is a widespread problem in the United States andthroughout the world. Urinary incontinence affects people of all agesand can severely impact a patient both physiologically andpsychologically.

In approximately 30% of the women suffering from urinary incontinence,incontinence is caused by intrinsic sphincter deficiency (ISD), acondition in which the valves of the urethral sphincter do not properlycoapt. In approximately another 30% of incontinent women, incontinenceis caused by hypermobility, a condition in which the muscles around thebladder relax, causing the bladder neck and proximal urethra to rotateand descend in response to increases in intraabdominal pressure.

Hypermobility may be the result of pregnancy or other conditions whichweaken the muscles. In an additional group of women with urinaryincontinence, the condition is caused by a combination of ISD andhypermobility.

In addition to the conditions described above, urinary incontinence hasa number of other causes, including birth defects, disease, injury,aging, and urinary tract infection.

Numerous approaches for treating urinary incontinence are available. Forexample, several procedures for stabilizing and/or slightly compressingthe urethra so as to prevent the leakage of urine have been developed.The stabilizing or compressive force may be applied directly by suturespassing through the soft tissue surrounding the urethra or,alternatively, may be applied by means of a sling located under theurethra and suspended by sutures. The sutures may be anchored to thepubic bone by means of bone anchors or, alternatively, the sutures maybe attached to other structures such as fascia.

A device for dissecting around a tubular structure such as the urethraor the bladder neck is available from Lone Star Medical Products. TheLone Star device has two shafts which can be positioned in the tissuebetween the urethra and the vaginal wall using cystoscopy, vaginal orrectal examination, or an examination of the position of the instrumentaround the urethra with the bladder opened. The two shafts can be lockedtogether to pinch the intervening tissue. A sharp blade is inserted intoone of the shafts and advanced into the second shaft, cutting the tissuein between the two shafts. The cut in the tissue can be expanded using aright angle clamp and an artificial sphincter guided by a sutureattached to the cutting blade of the device can be introduced into theexpanded cut.

With the Lone Star device, the distance between the two shafts cannot begradually adjusted. In addition, the ends of the shafts of the Lone Stardevice come in direct contact with the tissue or bone while beingadvanced towards the tissue between the urethra and the upper vaginalwall. The shafts of the Lone Star device are flat at their distal ends.

Thus, there is a need for devices which simplify treatments for urinaryincontinence and increase their safety. Sling application devices fortreating urinary incontinence which reduce the risk of inadvertentpinching of the urethra and undesirable scoring of tissue or bone duringadvancement of the device would be particularly desirable. It is alsodesirable to have a sling application device that does not employ aguiding suture and can create or maintain an opening in the tissuebetween the urethra and the upper vaginal wall without the use of aright angle clamp, thereby simplifying the procedure.

U.S. Pat. No. 5,611,515, issued Mar. 18, 1997 to Benderev et al.,introduces pioneering minimally invasive percutaneous and transvaginalbladder neck stabilization approaches. The percutaneous approach ofBenderev et al. involves stabilizing the bladder neck using a boneanchor which is percutaneously introduced from the abdominal side of thepatient. The transvaginal approach of Benderev et al. involvesstabilizing the bladder neck using a staple or bone anchor which istransvaginally placed into the pubic bone. There is also a need forfurther devices and methods for improving or maintaining urinarycontinence involving stabilization or compression of the bladder neck orurethra, particularly devices and methods of the present invention thatare less invasive than many of those currently available.

Part B

Urinary incontinence is a widespread problem in the United States andthroughout the world. Urinary incontinence affects people of all agesand can severely impact a patient both physiologically andpsychologically.

In approximately 30% of the women suffering from urinary incontinence,incontinence is caused by intrinsic sphincter deficiency (ISD), acondition in which the valves of the urethral sphincter do not properlycoapt. In approximately another 30% of incontinent women, incontinenceis caused by hypermobility, a condition in which the muscles around thebladder relax, causing the bladder neck and proximal urethra to rotateand descend in response to increases in intraabdominal pressure.Hypermobility may be the result of pregnancy or other conditions whichweaken the muscles. In an additional group of women with urinaryincontinence, the condition is caused by a combination of ISD andhypermobility.

In addition to the conditions described above, urinary incontinence hasa number of other causes, including birth defects, disease, injury,aging, and urinary tract infection.

Numerous approaches for treating urinary incontinence are available. Onesuch approach involves the use of a sling. At the present time, however,surgeons using a sling based procedure must grow or harvest autologoustissue or purchase processed cadaveric tissue, animal tissue, orsynthetic material from a supplier and fashion the sling during thesurgical procedure. Thus, during surgery, the surgeon must cut the slingto the desired dimensions and shape, and attach sutures to the sling. Inaddition to increasing surgical expense, these steps increase the timerequired for and complexity of the procedure, thereby increasingsurgical morbidity and mortality.

In addition, the slings currently in use are susceptible to tearing atthe sites where the sutures are attached to the sling. If the sutureattachment sites tear, the sling becomes dislodged and incontinence mayresult. Additional surgery is required to replace the dislodged slingand restore continence.

Thus, there remains a need for a prefabricated sling which overcomes theabove deficiencies. U.S. Pat. No. 5,611,515, issued Mar. 18, 1997 toBenderev et al., introduces pioneering minimally invasive percutaneousand transvaginal bladder neck stabilization approaches. The percutaneousapproach of Benderev et al. involves stabilizing the bladder neck usinga bone anchor which is percutaneously introduced from the abdominal sideof the patient. The transvaginal approach of Benderev et al. involvesstabilizing the bladder neck using a staple or bone anchor which istransvaginally placed into the pubic bone. The slings of the presentinvention may be used in several urethral or bladder neck stabilizationprocedures, including the minimally invasive percutaneous andtransvaginal procedures described below and those described in Benderevet al.

SUMMARY OF THE INVENTION

Part A

The present invention relates to devices and methods for use inpercutaneous and hiatal approaches treatments for urinary incontinence.In particular, the present invention relates to guide member placementdevices, sling application catheters, tissue dissectors/dilators, slingapplication devices and a sling application system, tissue expanders,grasping devices, and balloon catheters. Methods for using the precedingdevices to stabilize the bladder neck or the urethral floor in order tomaintain or improve urinary continence are also disclosed.

One aspect of the present invention is a guide member placement devicefor inserting a guide member in a body tissue. The guide memberplacement device comprises a shaft having a proximal end, a distal end,and a lumen extending therethrough. The lumen of the shaft is adaptedfor receiving a guide member. The distal end of the shaft has anengaging member for engaging another guide member placement device. Inone embodiment of the guide member placement device, the device furthercomprises a blunt dissection tip at the distal end of the shaft and ahandle with a lumen extending therethrough wherein the lumen of theshaft and the lumen of the handle are aligned. In a further embodiment,the blunt dissection tip is on a blunt dissector within the shaft and isextendable from and retractable in the shaft. In a further embodiment,the guide member placement device is adapted for use in urethral floorreconstruction procedures. In yet another embodiment, the guide memberplacement device is adapted for use in bladder neck stabilizationprocedures. In one embodiment of the guide member placement device, theengaging member comprises a male connector. In another embodiment of theguide member placement device, the engaging member comprises a femaleconnector. In yet another embodiment of the guide member placementdevice, the shaft has a straight proximal section, a bent intermediatesection and a distal end oriented at an angle of approximately 90degrees relative to the proximal section. In another embodiment, theguide member placement device further comprises a guide member removablypositioned in the lumen of the shaft. In one aspect of this embodiment,the guide member comprises a guide wire. In another aspect of thisembodiment, the guide member comprises a suture.

Another aspect of the present invention is a method of inserting a guidemember into a body tissue. A shaft of a first guide member placementdevice is inserted percutaneously and advanced through the body tissueto a central point through which the guide member will pass. A shaft ofa second guide member placement device is inserted percutaneously andadvanced through the body tissue to the central point through which theguide member will pass. An engaging member on a distal end of the shaftof the first guide member placement device is coupled to an engagingmember on a distal end of a shaft of a second guide member placementdevice such that a lumen in the shaft of the first guide memberplacement device is fluid communication with a lumen in the shaft of thesecond guide member placement device. A guide member is passed throughthe lumens of the coupled shafts of the first guide member placementdevice and the second guide member placement device. The shaft of thefirst guide member placement device and the shaft of the second guidemember placement device are removed from the body, thereby leaving theguide member in the body tissue. In one embodiment of the method, thefirst and second shafts are percutaneously inserted through first andsecond suprapubic incisions. In another embodiment of the method, theshafts of the first and second guide member placement devices areinserted into a pre-formed opening or pocket in the body tissue. Inanother embodiment of the method, the method further comprises the stepof creating an opening in the body tissue by extending and retracting ablunt dissector tip from at least one of the guide member placementdevices. In another embodiment of the method, the pre-formed opening orpocket is in the tissue between the urethra and the upper vaginal wallsuch that the guide member is left in the pre-formed opening or pocket.

Another aspect of the present invention is a sling application cathetercomprising a catheter having a sling therein, wherein the sling isreleasably engaged with the catheter. In one embodiment of the slingapplication catheter, the catheter has a pouch therein for releasablyengaging the sling. In one embodiment of the sling application catheter,the catheter is adapted to travel over a guide member. In yet anotherembodiment of the sling application catheter, the distal end of thecatheter is tapered. In yet another embodiment of the sling applicationcatheter, the distal end of the pouch is tapered. In one embodiment ofthe sling application catheter, the pouch is porous. In anotherembodiment of the sling application catheter, the pouch furthercomprises a stiffener for increasing its rigidity. The stiffener may bein the interior of the pouch or on the exterior of the pouch. In anotherembodiment of the sling application catheter, the stiffener is porous.

Another aspect of the present invention is a method of introducing asling into a body tissue. The method comprises the steps of passing asling application catheter catheter through the body tissue. The slingapplication catheter comprises a catheter having a sling therein whichis releasably engaged to the catheter. The sling is released form thesling application catheter, thereby introducing the sling into the bodytissue.

In one aspect of the method of introducing a sling into a body tissue,the method further comprises making a first incision and a secondincision and the step of passing the sling application catheter throughthe body tissue comprises passing the sling application catheter intothe first incision and out of the second incision. In one embodiment ofthe method of introducing a sling into a body tissue, the sling isreleased from the sling application catheter by withdrawing the slingfrom a pouch in the sling application catheter. In another embodiment,the sling application catheter is passed through the body tissue over aguide member. In yet another embodiment, the sling is introduced intothe tissue between the urethra and the upper vaginal wall. In stillanother embodiment, the first incision and the second incision aresuprapubic incisions. In another embodiment, the method furthercomprises the step of withdrawing the sling from the pouch by graspingan end of the sling while withdrawing the distal end of the slingapplication catheter out of the second suprapubic incision. In yetanother embodiment, the step of withdrawing the sling from the pouchcomprises withdrawing a sterile sling.

Another aspect of the present invention is a tissue dissector/dilatorfor creating and dilating an opening or pocket in a body tissue. Thetissue dissector/dilator comprises a body, a noncompliant shaft attachedto the body, a dissector carried on the shaft for creating an opening orpocket in the body tissue, and a dilator carried on the shaft fordilating the opening or pocket in the body tissue. In one embodiment,the shaft has a lumen extending therethrough and the dissector is withinthe lumen in the shaft and is axially movable, such that the dissectorcan be extended from and retracted in the shaft. In another embodiment,the shaft has a lumen extending therethrough and the dilator is withinthe lumen in the shaft and is axially movable, such that the dilator canbe extended from and retracted in said shaft. In another embodiment, theshaft has a lumen extending therethrough and both the dissector and thedilator are within the lumen of the shaft and are axially movable, suchthat the dissector and the dilator can be extended from and retracted inthe shaft. In one embodiment, the axially movable dissector and theaxially movable expandable dilator are integral. In another embodiment,the tissue dissector/dilator is adapted for use in bladder neckstabilization procedures.

In still another embodiment of the tissue dissector/dilator, the body ofthe tissue dissector/dilator further comprises a first control memberfor extending and retracting the axially movable integral dissector andexpandable dilator between a first position in which the dissectorextends from the shaft, a second position in which both the dissectorand the dilator extend from the shaft, and a third position in which thedissector and the dilator are retracted inside the shaft. In thisembodiment, the body of the tissue dissector/dilator also comprises asecond control member for expanding the dilator in the opening or pocketin the body tissue, thereby dilating the opening or pocket and forcollapsing the dilator following dilation of the opening or pocket. Inanother embodiment, the first control member for extending andretracting the axially movable integral dissector and expandable dilatorcomprises a spring return button which engages the axially movableintegral dissector and expandable dilator so as to extend or retractsaid axially movable integral dissector and expandable dilator. In stillanother embodiment, the spring return button can be positioned to lockthe axially movable integral dissector and expandable dilator in a fullyextended position. In yet another embodiment, the spring return buttonprovides a one to one stroke motion to the axially movable integraldissector and expandable dilator.

In a further embodiment of the tissue dissector/dilator, the axiallymovable integral dissector and expandable dilator is a cathetercomprising an outer tube having a lumen extending therethrough and atleast one expandable balloon in the lumen of the outer tube. In thisembodiment, the expandable balloon has an inflation tube at its proximalend and a blunt dissector at its distal end, wherein the inflation tubeis in fluid communication with the interior of the balloon. In stillanother embodiment, the second control member for expanding the dilatorcomprises a trigger on the body and a syringe in the body comprising aplunger, a reservoir, and a tip. In this embodiment, the tissuedissector/dilator also comprises a syringe locking mechanism, whereinthe tip of the syringe fixedly engages the syringe locking mechanism toplace the reservoir of the syringe in fluid communication with theballoon catheter, and the trigger engages the plunger of the syringesuch that squeezing the trigger depresses the plunger of the syringethereby dispensing fluid from the syringe and expanding the balloon ofthe catheter. In still another embodiment, the catheter furthercomprises a second lumen adapted for passage of a guide member. In afurther embodiment, the catheter further comprises a third lumen. Inanother embodiment, the third lumen is adapted for receiving anultrasound catheter. In still another embodiment, the third lumen isadapted for receiving an implant. In another embodiment, the third lumenis adapted for irrigation.

Another aspect of the present invention is a tissue dissector/dilatorfor creating and dilating an opening or pocket in a body tissuecomprising a body, a noncompliant shaft attached to said body, adissection means carried on the shaft for dissecting an opening orpocket in a body tissue, and a dilation means carried on the shaft fordilating the opening or pocket,

Another aspect of the present invention is a method of creating anddilating an opening or pocket in a body tissue. A noncompliant shaft ofa tissue dissector/dilator is percutaneously inserted into the bodytissue. The shaft is advanced through the body tissue. A dissector isextended from a distal end of the shaft to create a first opening orpocket in the body tissue and a dilator is extended from the distal endof the shaft. The dilator is expanded within the first opening or pocketto dilate the first opening or pocket. In one embodiment of the method,the tissue dissector/dilator is percutaneously inserted through asuprapubic incision. In another embodiment, the body tissue is thetissue between the urethra and the upper vaginal wall and the firstopening or pocket is perpendicular to the longitudinal axis of theurethra and extends from one side of the urethra to the other. Inanother embodiment the method further comprises percutaneously insertinga noncompliant shaft of a second tissue dissector/dilator into the bodytissue, advancing the noncompliant shaft of the second tissuedissector/dilator through the body tissue, extending a dissector from adistal end of the shaft of the second tissue dissector/dilator to createa second opening or pocket in the tissue, extending a dilator from thedistal end of the shaft of the second tissue dissector/dilator andexpanding said dilator within the second opening or pocket, therebydilating the second opening or pocket and forming from the first andsecond openings or pockets a continuous opening or pocket in the bodytissue. In a further embodiment, the second tissue dissector/dilator ispercutaneously inserted through a suprapubic incision. In yet anotherembodiment of the method, the body tissue is the tissue between theurethra and the upper vaginal wall and the continuous opening or pocketis perpendicular to the longitudinal axis of the urethra and extendsfrom one side of the urethra to the other.

Another aspect of the present invention is a sling application devicefor inserting a sling into a pocket in a body tissue. The slingapplication device comprises a first shaft and a second shaft. The firstand second shafts have lumens extending therethrough. The lumens havedimensions adapted for receiving a sling therein. The sling applicationdevice also comprises an adjuster for incrementally adjusting thedistance between said first and second shafts. In one embodiment, thelumens of the first and second shafts have dimensions adapted forreceiving a sling introducer having a sling releasably engaged thereto.In another embodiment, the sling application device further comprises afirst handle attached to the first shaft and a second handle attached tothe second shaft. In this embodiment, the first and second handles haveopenings therein which are in fluid communication with the lumens in theshafts to which the handles are attached and the first and secondhandles are adapted to be connected to one another. In anotherembodiment, the adjuster engages the first and second handles.

In one embodiment of the sling application device the first and secondshafts are curved. In still another embodiment, the first and secondshafts have a small radius 90° curve at their distal ends, such that thefirst and second shafts are adapted for use in urethral stabilizationprocedures. In another embodiment, the first and second shafts have aside bend. In yet another embodiment, the radius of curvature at thedistal ends of the first and second shafts is not planar with the axialportions of the shafts of the first and second shafts. In still anotherembodiment, the upper edges of the distal ends of the first and secondshafts are indented relative to the lower edges. In another embodiment,the first and second handles are adapted for interlocking. In a furtherembodiment, the adjuster comprises an articulating lock. In stillanother embodiment, the first shaft and the second shaft arecylindrical. In one embodiment, the first shaft and the second shaftcomprise flat tubes. In another embodiment, the portion of the firstshaft and the second shaft proximal to the bend is cylindrical and theportion distal to the bend is a flat tube. In another embodiment, theproximal portions of the first and second shafts are oriented at anangle of about 90° relative to the distal portions of the first andsecond shafts. In another embodiment, the sling application devicefurther comprises a blunt dissector for dissecting the body tissuewithout scoring or creasing tissue or bone with which it comes incontact. In this embodiment, the blunt dissector comprises a dissectorshaft adapted for insertion into the first and second shafts of thesling application device. The dissector shaft has a generally rigid tipat its distal end. The rigid tip protrudes from the distal ends of thefirst and second shafts of the sling application device when the bluntdissector is inserted into the first and second shafts of the slingapplication device. In yet another embodiment, the blunt dissectorcomprises an obturator.

Another aspect of the present invention is a sling introducer adaptedfor introducing a sling attached thereto into an opening or pocket in abody tissue without the use of sutures. The sling introducer comprises asling engager having the sling releasably engaged thereto. The slingengager is adapted for advancement through a first shaft and a secondshaft of a sling application device. The length of the sling introduceris at least equal to the sum of the lengths of the first and secondshafts of the sling application device. In one embodiment, the slingengager comprises a pouch for releasably engaging said sling. In anotherembodiment, the pouch has pores therein for permitting a solution toaccess said sling. In still another embodiment, the distal end of thepouch has a narrow lead. In a further embodiment, the pouch isreinforced.

Another aspect of the present invention is a tissue cutter for forming acavity in a tissue. The tissue cutter comprises an elongated housingadapted to fit within a shaft of a sling application device and anextendable and a retractable blade within the housing. The blade isadapted to form the cavity in the tissue. In one embodiment, the bladecomprises a razor. In another embodiment, the razor is sized such thatthe cavity formed with the razor has dimensions adapted for insertion ofa sling therein.

Another aspect of the present invention is a sling application system.The sling application system includes a sling application devicecomprising a first shaft and a second shaft. The first and second shaftsof the sling application device have lumens extending therethrough. Thelumens have dimensions adapted for receiving a sling introducer therein.The sling application device also comprises an adjuster forincrementally adjusting the distance between the first and secondshafts. The sling application system also includes a blunt dissector fordissecting a body tissue without scoring or creasing tissue or bone withwhich it comes in contact. The blunt dissector comprises a dissectorshaft adapted for insertion into the first and second shafts of thesling application device. The dissector shaft has a generally rigid tipat its distal end wherein the generally rigid tip protrudes from thedistal ends of the first and second shafts of the sling applicationdevice when the blunt dissector is inserted into the first and secondshafts. The sling application system also comprises a sling introducerfor introducing a sling attached thereto into an opening or pocket inthe body tissue without the use of sutures. The sling introducercomprises a sling engager having the sling releasably engaged thereto.The sling engager is adapted for advancement through the lumens of thefirst and second shafts of the sling application device wherein thesling introducer has a length sufficient to extend between the first andsecond shafts of the sling application device. In one embodiment, thesling application system further comprises a tissue cutter for forming acavity in the body tissue. The tissue cutter comprises an elongatedhousing adapted to fit within the second shaft of the sling applicationdevice and an extendable and retractable blade within the housing. Theblade is adapted to form a cavity in the body tissue.

Yet another aspect of the present invention is a method for introducinga sling into a body tissue. A first blunt dissector is inserted into afirst shaft of a sling application device. The first shaft having thefirst blunt dissector therein is inserted percutaneously and advancedthrough the body tissue. A second blunt dissector is inserted into asecond shaft of the sling application device. The second shaft havingthe second blunt dissector therein is inserted percutaneously andadvanced through the body tissue. The distance between the distal endsof said first and second shafts is decreased. A sling introducer havingthe sling releasably engaged thereto is advanced between the first andsecond shafts of the sling application device. The sling is releasedfrom the sling introducer. The first and second shafts are removed fromthe body tissue, thereby introducing the sling into the body tissue. Inone embodiment, the method further comprises making a first incision anda second incision wherein the first shaft of the sling applicationdevice is inserted into the first incision prior to advancing it throughthe body tissue and the second shaft of the sling application device isinserted into the second incision prior to advancing it through the bodytissue. In another embodiment, the sling is introduced into a pre-formedpocket in the tissue between the urethra and the vaginal wall. In afurther embodiment, the first incision and the second incision aresuprapubic incisions. In still another embodiment, the method furthercomprises inserting a tissue cutter into the first shaft of the slingapplication device and extending the tissue cutter into the body tissuebetween the distal ends of the first and second shafts, therebydissecting the body tissue.

Another aspect of the present invention is a balloon catheter comprisingan outer tube having a lumen extending therethrough and at least oneexpandable balloon adapted for dilating an opening or pocket in thetissue between the urethra and the upper vaginal wall. The expandableballoon has a proximal end and a distal end in the lumen of the outertube. The expandable balloon also has an inflation tube at its proximalend. The inflation tube is in fluid communication with the interior ofthe balloon. In one embodiment, the expandable balloon has a bluntdissection tip at its distal end which has sufficient rigidity to allowit to create an opening or pocket in the solid body tissue. In oneembodiment, the balloon catheter comprises a plurality of expandableballoons in fluid communication with the inflation tube. In anotherembodiment, the balloon catheter is adapted to fit in the lumen of alarge bore needle. In still another embodiment, the expandable balloonhas a flat profile. In another embodiment, the balloon further comprisesinternal non-expansive ribs. In yet another embodiment, the catheterextends into the interior of the balloon. In still another embodiment,the balloon is on the exterior surface of the catheter.

Another aspect of the present invention is a detachable member slingapplication device for introducing a sling having sutures attachedthereto into an opening or pocket in a body tissue. The detachablemember sling application device has a housing with an introduction shaftconnected thereto. The introduction shaft has a lumen extendingtherethrough which is adapted to receive the sling having suturesattached thereto. The detachable member sling application device alsohas a detachable member on the distal end of the introduction shaft. Thedetachable member is connected to at least one of the sutures attachedto the sling. In one embodiment, the detachable member sling applicationdevice further comprises an axially movable needle. In this embodiment,the needle comprises a needle shaft and a sharpened point. The needle islocated inside the lumen of the introduction shaft and is extendabletherefrom.

Another aspect of the present invention is a retrieval device forintroducing a sling into an opening or pocket in a body tissue,comprising a shaft having an engaging member at its distal end. Theengaging member is adapted to engage a detachable member connected to asuture attached to the sling.

Another aspect of the present invention is a method of stabilizing thebladder neck. A pocket or opening is formed in the tissue between theurethra and the upper vaginal wall. A sling application device isinserted into the pocket or opening. A sling is introduced into thepocket or opening with the sling application device. The sling issecured to tissue or bone to stabilize the bladder neck. In oneembodiment the method further comprises providing a detachable membersling application device. The detachable member sling application devicehas a housing with an introduction shaft connected thereto. Theintroduction shaft has a lumen extending therethrough which is adaptedto receive the sling having sutures attached thereto. The detachablemember sling application device also has a detachable member on thedistal end of the introduction shaft. The detachable member is connectedto at least one of the sutures attached to the sling. In thisembodiment, the step of inserting a sling application device into thepocket or opening comprises inserting the detachable member slingapplication device into the opening or pocket. Another step in thisembodiment comprises detaching a detachable member from a distal end ofthe shaft of the detachable member sling application device. Thedetachable member is connected to the sling. Another step in thisembodiment comprises introducing a shaft of a retrieval device into theopening or pocket. Yet another step in this embodiment comprisesengaging the detachable member with an engaging member on the shaft ofthe retrieval device. Another step of this embodiment compriseswithdrawing the shaft of the retrieval device from the opening orpocket, thereby introducing the sling of the detachable member slingapplication device into the opening or pocket. In another embodiment,the method further comprises extending an axially movable needle from adistal end of the shaft of the detachable member sling applicationdevice into the body tissue and toggling the needle to move thedetachable member within the opening or pocket. In still anotherembodiment, the opening or pocket is in a hiatus between a urethra andan upper vaginal wall. In another embodiment, the method furthercomprises the step of expanding the opening or pocket in the hiatususing a balloon catheter having at least one expandable balloon with ablunt dissection tip at its distal end. In this embodiment, the bluntdissection tip has sufficient rigidity to allow it to make the openingin the body tissue when contacting the tissue.

Another aspect of the present invention is a device for expanding anopening or pocket within a body tissue. The device comprises a tubehaving a lumen extending therethrough, an axially movable expandable andcollapsible expansion basket attached to the tube for insertion into theopening or pocket within the body tissue and expansion thereof, and anexpansion and collapse control in communication with the expandable andcollapsible basket for expanding and collapsing the basket. In oneembodiment, the basket comprises a plurality of wires. In anotherembodiment, the expansion and collapse control comprises a pull wire.

Another aspect of the present invention is a grasping device adapted forinsertion into a lumen of an expansion device having an expansion basketfor expanding an opening or pocket within a body tissue. The graspingdevice comprises a catheter having a grasping member on its distal endfor grasping a suture or guide member which has been advanced into theexpansion basket of the expansion device. In one embodiment, thegrasping member comprises a self-expanding basket. In anotherembodiment, the self-expanding basket is adapted to fit inside theexpansion basket of the expansion device when the expansion basket ofthe expansion device is in an expanded configuration.

Another aspect of the present invention is a method of creating a pocketin the tissue between the urethra and the upper vaginal wall comprisinghydrodissecting the tissue.

Another aspect of the present invention is a method for holding a pocketin a body tissue in an open position. A lumen is made in the bodytissue. The lumen in the body tissue is expanded to create the pocket inthe body tissue. An expansion device is inserted into the pocket and anexpansion basket on the expansion device is expanded in the pocket,thereby holding the pocket in the open position. In one embodiment, thebody tissue comprises a hiatus between a urethra and an upper vaginalwall. In another embodiment, the lumen is expanded with a ballooncatheter. In another embodiment, the method further comprises insertinga suture or guide member through a suprapubic incision into the pocket,inserting a grasping device comprising a catheter having a graspingmember on its distal end into a lumen of the expansion device, graspingthe suture or guide member with the grasping device, and withdrawing thesuture or guide member to a desired position. In one embodiment, thesuture or guide member is grasped under direct vision.

Yet another aspect of the invention is a method of introducing a slinginto an opening in a body tissue comprising holding a pocket or openingin a body tissue in an open position with an expansion basket asdescribed above, grasping a suture or guide wire within the expandedopening as described above, and drawing the suture or guide wire to adesired position. The method is performed on each side of the urethrasuch that two sutures extend from the patient's body. The two suturesare tied together and used to guide a sling into the opening. In oneembodiment, the body tissue comprises a hiatus between the urethra andthe upper vaginal wail.

Yet another aspect of the invention is a method of introducing a slinginto an opening in a body tissue comprising holding a pocket or openingin a body tissue in an open position with an expansion basket asdescribed above, grasping a suture or guide wire within the expandedopening as described above, and drawing the suture or guide wire to adesired position. The method is performed on each side of the urethrasuch that two sutures extend from the patient's body. A sling isattached to the two sutures outside of the patient's body and introducedinto the opening in the body tissue. In one embodiment, the body tissuecomprises a hiatus between the urethra and the upper vaginal wall.

Part B

The present invention relates to prefabricated urethral stabilizationslings, methods of making the slings, methods of attaching sutures tothe slings, kits comprising the slings, and methods of using the slingsto treat urinary incontinence.

One aspect of the invention is a prefabricated sling for improvingurinary continence which is made of a biocompatible material and has anelongate shape adapted for urethral stabilization. The biocompatiblematerial has a central portion extending longitudinally between a firstend portion and a second end portion and at least a pair of suturereceiving sites which comprise a first site located in the first endportion of the material and a second site located in the second endportion of the material. The first site is adapted for receiving atleast a first suture and the second site is adapted for receiving atleast a second suture. The first site and the second site are generallydisposed along a line extending longitudinally relative to the sling.

In one embodiment of the sling, the biocompatible material isdirectionally oriented. For example, the biocompatible directionallyoriented material may be longitudinally oriented. In a furtherembodiment, the first and second end portions of the directionallyoriented material have at least one presewn edge and are generally atleast twice as thick as the central portion. In yet another embodiment,the first and second suture receiving sites have an inner diameter atleast equal to the diameter of the sutures.

In a further embodiment of the sling, the biocompatible material isabsorbable. In some embodiments of the sling, the biocompatible materialis woven.

In yet another embodiment of the sling, the biocompatible material iscoated. In some embodiments, the coating on the biocompatible materialis absorbed after implantation to facilitate tissue ingrowth into thebiocompatible material.

In another embodiment of the sling, the biocompatible material isimpregnated with an antibiotic. In one embodiment, the sling isimpregnated with bacitracin. In another embodiment, the sling isimpregnated with polymixim. In another embodiment the sling isimpregnated with neomycin.

In some embodiments, the sling is capable of releasing a drug. Infurther embodiments, the drug is released over time.

The sling may have a visual indicator for indicating the position of thesling relative to the urethra. The visual indicator may comprise atleast one transversely extending line in the central portion of thematerial.

In some embodiments, the sling has a stabilizer for furtherstrengthening and further reducing buckling of the sling, the stabilizerbeing located in the first and second end portions of the sling.

In some embodiments, the material around the periphery of the suturereceiving sites is reinforced. In other embodiments, the suturereceiving sites are strengthened with a reinforcing device.

Another aspect of the present invention is a prefabricated sling forimproving urinary continence comprising a biocompatible material havingan elongate shape adapted for urethral stabilization. In this aspect ofthe invention, the biocompatible material has a central portionextending longitudinally between a first end portion and a second endportion. In this aspect of the invention, the sling also has integralattachment members for suspending the sling.

Yet another aspect of the present invention is a kit for performing aurethral stabilization. The kit comprises a sterile biocompatiblematerial having an elongate shape adapted for urethral stabilization.The biocompatible material has a central portion extendinglongitudinally between a first end portion and a second end portion. Thebiocompatible material also has at least a pair of suture receivingsites. The pair of suture receiving sites comprises a first suturereceiving site located in the first end portion of the biocompatiblematerial and a second suture receiving site located in the second endportion of the biocompatible material. The first suture receiving siteis adapted for receiving at least a first suture, and the second suturereceiving site is adapted for receiving at least a second suture. Thefirst suture receiving site and the second suture receiving site aregenerally disposed along a line extending longitudinally relative to thesling.

In one embodiment of the kit, the sling is packaged. In anotherembodiment of the kit, the first and second suture receiving sites areapertures. In still another embodiment of the kit, the biocompatiblematerial has at least a first and a second suture secured thereto. In afurther embodiment of the kit, the biocompatible material isfilamentous.

In still another embodiment, the filamentous material is collagencoated. In some embodiments of the kit, the sutures are looped throughthe apertures.

Yet another aspect of the present invention is a method of making asling for improving urinary continence. A biocompatible material is cutinto an elongate shape adapted for urethral stabilization such that thematerial has a central portion extending longitudinally between a firstend portion and a second end portion. At least a pair of suturereceiving sites is formed in the material prior to surgery. The pair ofsuture receiving sites comprises a first site located in the first endportion of the material and a second site located in the second endportion of the material. The first site is adapted for receiving atleast a first suture and the second site is adapted for receiving atleast a second suture. The first site and the second site are generallydisposed along a line extending longitudinally relative to the sling. Inone embodiment, the method further comprises the steps of securing atleast a first suture to the first site and securing at least a secondsuture to the second site. In another embodiment, the method furthercomprises the step of sterilizing the sling. In yet another embodiment,the method further comprises the step of applying an antibiotic to thesling. In still another embodiment, the method further comprises thestep of packaging the sling.

Yet another aspect of the present invention is a method of stabilizing abladder neck to improve urinary incontinence. In one step of the method,a sling comprising a biocompatible material having an elongate shapeadapted for urethral stabilization is provided. The material has acentral portion extending longitudinally between a first end portion anda second end portion. The sling also comprises at least a pair of suturereceiving sites. In another step of the method, a suture is secured to abone anchor. In another step of the method, the anchor is positioned ina pubic bone. In yet another step of the method, the suture is securedto at least one of the suture receiving sites in the sling. The suturereceiving sites are adapted for receiving at least one suture. Thesuture receiving sites comprise a first suture receiving site located inthe first end portion of the material and a second suture receiving sitelocated in the second end portion of the material. The first suturereceiving site is adapted for receiving at least a first suture and thesecond suture receiving site is adapted for receiving at least a secondsuture. The first suture receiving site and the second suture receivingsite are generally disposed along a line extending longitudinallyrelative to the sling. In another step of the method, the bladder neckis stabilized with the sling. In one embodiment, the method furthercomprises introducing the sling percutaneously. In another embodiment ofthe method, the sling is introduced without invasive surgery.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an embodiment of a guide member placementdevice having a male connector at the distal end of the shaft.

FIG. 2 is an assembled cross-sectional view of the guide memberplacement device of FIG. 1 showing the internal structure of the device.

FIG. 3 is a side view of an embodiment of a guide member placementdevice having a female connector at the distal end of the shaft.

FIG. 4 is an enlarged cross-sectional view taken along line 4-4 of thedistal end of the shaft of a guide member placement device of FIG. 1.

FIG. 5 is an enlarged cross-sectional view taken along line 5-5 of thedistal end of the shaft of the guide member placement device of FIG. 3.

FIG. 6 is a cross-sectional view showing the distal ends of the shaftsof the guide member placement devices of FIGS. 1 and 3 coupled throughtheir male and female connectors.

FIG. 7A is an enlarged view of the distal portion of the shaft of theguide member placement device taken along line 7A-7A of FIG. 1.

FIG. 7B is an enlarged view of the distal portion of the shaft of theguide member placement device taken along line 7B-7B of FIG. 3.

FIG. 7C is an enlarged view of the distal portion of the shaft of aguide member placement device having an alternate shaft configuration inwhich the curve is smoothly curved.

FIG. 7D is an enlarged view of the distal end of the shaft of a guidemember placement device having an alternate shaft configuration in whichthe curve is smoothly curved.

FIG. 8 shows the blunt dissection tip extending into a tissue from thedistal end of the shaft of a guide member placement device having a maleconnector to create an opening in the tissue.

FIG. 9 shows a first guide member placement device that has beeninserted into a first suprapubic incision and advanced into the bodytissue.

FIG. 10 shows a guide member placement device that has been advancedinto the tissue between the urethra and the upper vaginal wall such thatthe distal end of the shaft extends transversely between the urethra andthe upper vaginal wall in the plane defined by the longitudinal axes ofthe urethra and the vagina.

FIG. 11 shows the blunt dissection tip extending into a tissue from thedistal end of the shaft of a guide member placement device having afemale connector to create an opening in the tissue.

FIG. 12 shows a second guide member placement device that has beeninserted into a second suprapubic incision and advanced into a bodytissue.

FIG. 13 shows the first and second guide member placement devices in thetissue between the urethra and the upper vaginal wall with the distalends of their shafts connected to one another.

FIG. 14 shows a guide member extending between the two suprapubicincisions after removal of the first and second guide member placementdevices.

FIG. 15 is a plan view of a sling application catheter.

FIG. 16 is an enlarged view of the distal end of the sling applicationcatheter taken along line 16-16 of FIG. 15.

FIG. 17 is a cross-sectional view taken along line 17-17 of the slingapplication catheter of FIG. 16.

FIG. 18 is an enlarged view of the distal end of a sling applicationcatheter having a reinforcing stiffener within the pouch.

FIG. 19 is a cross-sectional view taken along line 19-19 of the slingapplication catheter of FIG. 18.

FIG. 20 is an enlarged view of the distal end of a sling applicationcatheter having a pouch made of a porous material.

FIG. 21 shows a sling application catheter being inserted into a firstsuprapubic incision with a guide member extending through the lumen ofthe catheter.

FIG. 22 shows the sling being withdrawn from the pouch of a slingapplication catheter that has been advanced into the tissue between theurethra and the upper vaginal wall.

FIG. 23 shows the sling extending between the first and secondsuprapubic incisions and passing through the tissue between the urethraand the upper vaginal wall.

FIG. 24 is a plan view of a tissue dissector/dilator in which the springreturn button is at the most proximal point and the blunt dissection tipand the expandable balloon are retracted within the shaft.

FIG. 25 is a plan view of the tissue dissector/dilator in which thespring return button has been advanced to the locked position and theexpandable balloon and blunt dissection tip are fully extended from theshaft.

FIG. 26 is a side view of a balloon catheter with a blunt dissection tipat its distal end.

FIG. 27 is a plan view of a tissue dissector/dilator in which the springreturn button has been advanced towards the distal end of the slide andthe blunt dissection tip extends from the shaft.

FIG. 28 is a plan view a tissue dissector/dilator in which the triggerhas been squeezed, causing the balloon to inflate.

FIG. 29 is a plan view of an alternate embodiment of the tissuedissector/dilator.

FIG. 30 shows the distal end of the shaft of a tissue dissector/dilatorbeing advanced until it intersects the tissue between the urethra andthe upper vaginal wall at approximately mid-thickness and in a directionwhich would permit the expandable balloon to advance perpendicular tothe axial direction of the urethra.

FIG. 31 shows the blunt dissection tip being extended from the distalend of the shaft into the tissue between the urethra and the uppervaginal wall thereby dissecting a first opening in the tissue.

FIG. 32 shows the expandable balloon extended into the first opening inthe tissue between the urethra and the upper vaginal wall which wascreated with the blunt dissection tip.

FIG. 33 shows the balloon being expanded in the first opening in thetissue thereby dilating the first opening.

FIG. 34 shows a second tissue dissector/dilator with its blunt tipdissecting a second opening in the tissue between the urethra and theupper vaginal wall which is aligned with the first opening in thetissue.

FIG. 35 shows the expandable balloon extended into the second opening.

FIG. 36 shows the expandable balloon expanded within the second openingthereby dilating the body tissue.

FIG. 37 shows a continuous opening in the tissue between the urethra andthe upper vaginal wall.

FIG. 38A is a perspective view of a sling application device.

FIG. 38B is a plan view taken along line 3813-3813 of the slingapplication device of FIG. 38A showing the tab on the locking button.

FIG. 39 is a side-view of the sling application device.

FIG. 40 is a cross-sectional view taken along line 40-40 of the firstshaft of the sling application device of FIG. 39.

FIG. 41 is a cross-sectional view taken along line 41-41 of the secondshaft of the sling application device of FIG. 40.

FIG. 42 is a side view of an alternate embodiment of the slingapplication device in which the portion of the shafts proximal to thebend is cylindrical and the portion of the shafts distal to the bend isa flat tube.

FIG. 43 is a cross-sectional view taken along line 43-43 of the portionof the first shaft distal to the bend of the sling application device ofFIG. 42.

FIG. 44 is a cross-sectional view taken along line 44-44 of the portionof the first shaft proximal to the bend of the sling application deviceof FIG. 42.

FIG. 45 is a side view of an alternate embodiment of the slingapplication in which the shafts are flat along their entire length.

FIG. 46 is a cross-sectional view taken along line 46-46 of the firstshaft of the sling application device of FIG. 45.

FIG. 47 is a side view of an alternate embodiment of the slingapplication device in which the shafts have a side bend.

FIG. 47A is a plan view of the first shaft taken along line 47A-47A ofthe sling application device of FIG. 47.

FIG. 47B is a plan view of the second shaft taken along line 4713-4713of the sling application device of FIG. 47.

FIG. 48 is a side view of a sling application device in which the shaftshave a 90° twist.

FIG. 49 is a perspective view of the distal ends of the first and secondshafts of a sling application device in which the upper edges of thedistal ends of the shafts are slightly indented relative to the loweredges.

FIG. 50 is a side view of an obturator for use with the slingapplication device.

FIG. 51 is a plan-view of a sling introducer.

FIG. 52 is a cross-sectional view taken along line 52-52 of the slingintroducer of FIG. 51.

FIG. 53 is a cross-sectional view of a cutter showing the internalstructure of the device.

FIG. 54 shows the first shaft of the sling application device beingadvanced into a pre-formed opening in the tissue between the urethra andthe upper vaginal wall.

FIG. 55 shows the distal ends of the first and second shafts of thesling application device opposing each other in the opening in tissuebetween the urethra and the upper vaginal wall.

FIG. 56 shows the first and second handles of the sling applicationdevice locked together.

FIG. 57 shows the distance between the distal ends of the first andsecond shafts of the sling application device being decreased as theadjuster is advanced to a position in between the proximal point and thedistal point of the guide.

FIG. 58 shows the tissue between the distal ends of the first and secondshafts of the sling application device being compressed when theadjuster is advanced to the distal end of the guide.

FIG. 59 shows an opening in the tissue between the urethra and the uppervaginal wall being created by a cutter dissecting the tissue between thedistal ends of the first and second shafts of the sling applicationdevice.

FIG. 60 shows the sling introducer being inserted into the second shaftof the sling application device.

FIG. 61 shows the sling being withdrawn from the sling introducer as thesling introducer is advanced through the tissue between the urethra andthe upper vaginal wall.

FIG. 62 shows the sling fully withdrawn from the sling introducer andlocated within the first and second shafts of the sling applicationdevice.

FIG. 63 shows the second shaft of the sling application device beingremoved from the patient's body.

FIG. 64 shows the first shaft of the sling application device beingremoved from the patient's body.

FIG. 65 shows the sling extending between the suprapubic incisions andpassing through the tissue between the urethra and the upper vaginalwall.

FIG. 66 is a side view of a detachable member sling application device.

FIG. 67 is a side view of a retrieval device.

FIG. 68 shows the creation of an opening in the tissue between theurethra and the upper vaginal wall by hydrodissection.

FIG. 69 shows the shaft of a detachable member sling application devicesling application device being advanced to a pocket or opening in thetissue between the urethra and the upper vaginal wall.

FIG. 70 shows the sharpened point of the needle of the detachable membersling application device extending through the upper vaginal wall.

FIG. 71 shows the needle of the detachable member sling applicationdevice being secured on the vaginal side with a hemostat.

FIG. 72 shows the detachable cup being detached from the distal end ofthe shaft of the detachable member sling application device.

FIG. 73 shows the needle of the detachable member sling applicationdevice being toggled.

FIG. 74 shows the shaft of a retrieval device being advanced through asecond suprapubic incision into the pocket.

FIG. 75 shows the shaft of the retrieval device being inserted into thedetachable cup and engaging the detachable cup.

FIG. 76 shows the needle being removed from the vagina.

FIG. 77 shows the sutures connected to the sling being pulled out of theshaft of the detachable cup sling application device.

FIG. 78 shows the shaft of the retrieval device being withdrawn from thepocket or opening, pulling the sling out of the shaft of the detachablemember sling application device.

FIG. 79 shows the shafts of the retrieval device and the detachablemember sling application device being withdrawn from the pocket.

FIG. 80 shows the sling located in the opening in the tissue between theurethra and the upper vaginal wall with the sutures extending throughthe incisions to the outside of the patient's body.

FIG. 81 shows the marks on the sutures being aligned to ensure centeringof the sling beneath the urethra within the opening in the tissuebetween the urethra and the upper vaginal wall.

FIG. 82 is a side view of a balloon catheter having two expandableballoons joined at their distal ends.

FIG. 83 shows the balloon catheter of FIG. 82 with the balloonsexpanded.

FIG. 84 is a plan view of the balloon catheter having a flat profileballoon.

FIG. 85 is a cross-sectional view taken along line 85-85 of the ballooncatheter of FIG. 84.

FIG. 86 is a cross-sectional view taken along line 86-86 of the ballooncatheter of FIG. 84.

FIG. 87 is a cross-sectional view of a tissue expander.

FIG. 88 is a side view of a grasping device.

FIG. 89 shows the target site for insertion of a device for creating alumen in the hiatal tissue between the urethra and the upper vaginalwall.

FIG. 90 shows the urethra straightened with a Foley catheter.

FIG. 91 shows a large bore needle being inserted into the hiatal tissuebetween the urethra and the upper vaginal wall.

FIG. 92 shows the needle partially retracted such that the lumen createdby the needle provides an access channel.

FIG. 93 shows a balloon catheter being advanced beyond the tip of theneedle into the lumen created in the hiatal tissue.

FIG. 94 shows the balloon of the balloon catheter being inflated todilate the tissue around the lumen created in the hiatal tissue.

FIG. 95 shows the tissue expander being advanced beyond the tip of theneedle into the lumen created in the hiatal tissue.

FIG. 96 shows the tissue expander in the expanded configuration withinthe lumen created in the hiatal tissue.

FIG. 97 shows a suture passing through the expansion basket of thetissue expander and into the self expanding basket of the graspingdevice.

FIG. 98 shows the grasping device grasping the suture.

FIG. 99 shows the grasping device being withdrawn from the rigid tubeand drawing the suture towards the outside of the patient's body.

FIG. 100 is a plan view of a preferred embodiment of the sling of thepresent invention.

FIG. 101A is a plan view of a parallelogram shaped embodiment of thesling of the present invention.

FIG. 101B is a plan view of a hexagonal shaped embodiment of the slingof the present invention.

FIG. 101C is a plan view of a rectangular shaped embodiment of the slingof the present invention.

FIG. 102A is a plan view of a preferred embodiment of the sling of thepresent invention showing preferred dimensions.

FIG. 102B is a cross-sectional view of the sling taken along line102B-102B of FIG. 102A.

FIG. 103A is a partial top view of an end portion of a sling having asingle suture receiving site.

FIG. 103B is a partial top view of a rounded end portion of a slinghaving two suture receiving sites.

FIG. 103C is a partial top view of an end portion of a sling havingthree suture receiving sites.

FIG. 104A is an enlarged top view of an end portion of a sling in whichthe suture receiving site is an aperture.

FIG. 104B is a cross-sectional view of the end portion taken along line104B-104B of FIG. 104A.

FIG. 104C is an enlarged top view of an end portion of a sling having areinforcing device in the suture receiving site.

FIG. 104D is a cross-sectional view of the end portion taken along line104D-104D of FIG. 104C.

FIG. 104E is an enlarged top view of an end portion of a sling having analternative reinforcing device in the suture receiving site.

FIG. 104F is a cross-sectional view of the end portion taken along line104F-104F of FIG. 104E.

FIG. 104G is an enlarged top view of an end portion of a sling havingreinforced material around the periphery of the suture receiving site.

FIG. 104H is a cross-sectional view of the end portion taken along line104H-104H of FIG. 104G.

FIG. 104I is an enlarged top view of an end portion of a sling havingreinforced material around an alternative suture receiving site.

FIG. 104J is a cross-sectional view of the end portion taken along line104J-104J of FIG. 104I.

FIG. 104K is an enlarged top view of an end portion of a sling in whichthe suture receiving site is an aperture and the material around theperiphery of the suture receiving site has been reinforced by heatsealing or ultrasonically sealing.

FIG. 104L is a cross-sectional view of the end portion taken along line104L-104L of FIG. 104K.

FIG. 105A is a plan view of an unfolded parallelogram shaped piece ofbiocompatible material.

FIG. 105B is a plan view of a hexagonal shaped piece of materialobtained by folding the material of FIG. 105A as indicated by the arrowsin FIG. 105A.

FIG. 105C is a plan view of a hexagonal shaped sling in which apertureshave been formed as suture receiving sites in the end portions of thesling.

FIG. 105D is a cross-sectional view of the hexagonal shaped sling takenalong line 105D-105D of FIG. 105C.

FIG. 105E is the cross-sectional view of FIG. 105D showing suturessecured to the apertures of the sling.

FIG. 105F is a plan view of an unfolded rectangular shaped piece ofbiocompatible material.

FIG. 105G is a plan view of a rectangular shaped piece of materialobtained by folding the material of FIG. 105F as indicated by the arrowsin FIG. 105F.

FIG. 105H is a plan view of a rectangular sling in which apertures havebeen formed as suture receiving sites in the end portions of the sling.

FIG. 105I is a cross-sectional view of the rectangular shaped slingtaken along line 1051-1051 of FIG. 105H.

FIG. 105J is the cross-sectional view of FIG. 105I showing suturessecured to the apertures of the sling.

FIG. 105K is a plan view of an unfolded rectangular piece ofbiocompatible material.

FIG. 105L is a plan view of a parallelogram shaped piece of materialobtained by folding the material of FIG. 105K as indicated by the arrowsin FIG. 105K.

FIG. 105M is a plan view of a parallelogram shaped sling in whichapertures have been formed as suture receiving sites in the end portionsof the sling.

FIG. 105N is a cross-sectional view of the parallelogram shaped slingtaken along line 105N-105N of FIG. 105M.

FIG. 105O is the cross-sectional view of FIG. 105N showing suturessecured to the apertures of the sling.

FIG. 106A is a schematic plan view of a parallelogram shaped piece ofbiocompatible material having longitudinally oriented filaments, grains,striations, or polymeric chains.

FIG. 106B is a cross-sectional view of the material taken along line106B-106B of FIG. 106A.

FIG. 106C is an enlarged view of the material taken along line 106C-106Cof FIG. 106A.

FIG. 106D is an enlarged schematic view of biocompatible material havingtransversely oriented filaments, grains, striations, or polymericchains.

FIG. 106E is an enlarged schematic view of biocompatible material havingdiagonally oriented filaments, grains, striations, or polymeric chains.

FIG. 106F is a schematic plan view of a hexagonal shaped sling obtainedby folding the material of FIG. 106A as indicted by the arrows in FIG.106A and forming apertures as suture receiving sites in the end portionsof the sling.

FIG. 106G is an enlarged top view of the sling taken along line106G-106G of FIG. 106F showing the filaments, grains, striations, orpolymeric chains in an upper layer of an end portion of the slingcrossing the filaments, grains, striations, or polymeric chains in theunderlying layer.

FIG. 107A is an enlarged top view of an end portion of a sling having asuture looped through a plurality of suture receiving sites.

FIG. 107B is a cross-sectional view of the sling taken along line107B-107B of FIG. 107A.

FIG. 107C is an enlarged top view of an end portion of a sling having asuture threaded through a suture receiving site.

FIG. 107D is a cross-sectional view of the sling taken along line107D-107D of FIG. 107C.

FIG. 107E is an enlarged top view of an end portion of a sling showing asuture looped around the suture receiving site and an edge of the sling.

FIG. 107F is a cross-sectional view of the sling taken along line107F-107F of FIG. 107E.

FIG. 108A is a plan view of an end portion of a sling having astabilizer attached thereto.

FIG. 108B is a cross-sectional view of the sling taken along line108B-108B of FIG. 108A.

FIG. 108C is a plan view of an end portion of a sling having astabilizer between the suture receiving sites.

FIG. 108D is a cross-sectional view of the sling taken along line108D-108D of FIG. 108C.

FIG. 109A is a plan view of a generally rectangular shaped sling withbilaterally extending integral attachment members.

FIG. 109B is a plan view of a generally hexagonal shaped sling withbilaterally extending integral attachment members.

FIG. 110 is a sagittal section of a female pelvis illustrating thelocation of the sling of the present invention relative to the bladderneck and the pubic bone.

FIG. 111 is a schematic cross-sectional view taken through the urethraand upper vaginal wall illustrating an incision in the upper vaginalwall.

FIG. 112 is a schematic cross-sectional view taken through the urethraand upper vaginal wall illustrating a bilaterally extending pocketcreated by blunt dissection.

FIG. 113 is a schematic view of a sling of the present inventionpositioned in the pocket of FIG. 112, the sling being suspended fromsutures secured to a bone anchor implanted in the pubic bone.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Part A

The present invention relates to methods and devices for creatingopenings or pockets in body tissues and/or dilating body tissues. Theguide member placement devices, sling application catheters, tissuedissector/dilators, sling application devices, sling applicationsystems, detachable member sling application devices, retrieval devices,and balloon catheters of the present invention may be usedpercutaneously or in conjunction with laparoscopic techniques. In suchlaparoscopic procedures, trocars are placed in the abdomen and theabdomen is insufflated with CO₂, causing it to distend. The devices areintroduced into the patient's body via the trocars, and the procedure isvisualized with a laparoscope.

The devices of the present invention may be used in a wide variety ofmedical procedures, but are particularly well suited for urethral floorreconstruction procedures such as bladder neck stabilization orsuspension procedures in which a sling is used to maintain or improveurinary continence by stabilizing and/or slightly compressing theurethra or by creating a non-moveable pelvic floor. Slings suitable foruse in bladder neck stabilization procedures and methods for implantingthem are disclosed in U.S. patent application Ser. No. 09/023,398,entitled “Stabilization Sling for Use in Minimally Invasive PelvicSurgery” (VESITEC.023A), filed Feb. 13, 1998, now issued U.S. Pat. No.6,042,534, issued Mar. 28, 2000, and the identically titled U.S.Provisional Patent Application Ser. No. 60/038,379, filed Feb. 13, 1997,the disclosures of which are incorporated herein by reference.

The present invention is particularly well suited for bladder neckstabilization procedures for treating urinary incontinence in females.The bladder neck stabilization procedures for which the presentinvention is especially well suited involve the creation of an openingor pocket in the tissue between the urethra and the upper vaginal wall,which is called the hiatus. The sling is then inserted in the opening orpocket. Sutures or integral attachment members at the ends of the slingare attached to the pubic bone or surrounding tissue and the tension isadjusted to slightly compress or stabilize the urethra by providing aplatform to reduce distension resulting from internal pressures, therebymaintaining or improving urinary continence. Suitable methods anddevices for adjusting the tension on the sutures are disclosed in U.S.Pat. No. 5,611,515, issued Mar. 18, 1997 to Benderev et al., thedisclosure of which is incorporated herein by reference.

The opening or pocket may be created in a variety of ways. In oneapproach, the opening or pocket is created by introducing an expandableballoon into the tissue between the urethra and the upper vaginal wall.When the balloon is expanded, the surrounding tissue is dilated or torn,generating an opening or pocket of sufficient size to receive the sling.

In an alternative approach, the opening or pocket is created byhydrodissection. In this approach, a bolus of saline or other sterilesolution is injected into the tissue between the urethra and the uppervaginal wall, resulting in an opening or pocket sized to receive thesling. The bolus of saline may be administered by positioning a syringeinside the vagina and piercing the vaginal wall with the needle of thesyringe such that the tip of the needle is in the tissue between theurethra and the upper vaginal wall. Alternatively, the bolus of salinemay be administered directly into the hiatal tissue without piercing thevaginal wall.

The volume of saline injected into the tissue in the hydrodissectionprocedure is too large to be rapidly absorbed such that the tissue mustseparate to accommodate the saline bolus. Preferably, the volume ofsaline introduced into the tissue is from about 4 cc to about 10 cc.More preferably, the volume of saline is about 4 to about 5 cc.

In yet another approach, the opening or pocket is created by dissectingthe tissue between the urethra and the upper vaginal wall with acombination of blunt dissectors and sharp cutters.

The opening or pocket may be created and the sling may be introduced bytaking a variety of routes through the patient's body. In one approach,called the percutaneous approach, the opening or pocket is created bymaking suprapubic incisions into which a device for introducing anopening or pocket in a body tissue or dilating a body tissue isinserted. The device is advanced through the patient's body tissue intothe tissue between the urethra and the upper vaginal wall where theopening or pocket is to be created. In some instances, the device forintroducing an opening or pocket in a body tissue or dilating a bodytissue may also introduce the sling into the opening.

In another approach, called the hiatal approach, the opening or pocketis created and the sling is introduced by directly accessing the tissuebetween the urethra and the upper vaginal wall. In this procedure theopening or pocket can be created without making suprapubic or vaginalincisions.

In other approaches, the opening or pocket is created directly in thetissue between the urethra and the upper vaginal wall and the sling isintroduced with a device advanced into the opening or pocket from asuprapubic or vaginal incision.

The devices and procedures described briefly above are discussed ingreater detail in the following sections. It will be appreciated bythose of skill in the art that any of the disclosed devices and methodsfor creating an opening or pocket can be combined with any of thedisclosed devices and methods for introducing a sling into the openingor pocket.

Guide Member Placement Device

One aspect of the present invention relates to methods in which thesling is introduced over a guide member and devices for use in suchmethods. The guide member may be a suture, guidewire, or other structuresuitable for guiding a sling to a desired location.

In one embodiment, the opening or pocket in which the sling isintroduced is created first and the guide member is then passed throughthe opening or pocket. In this embodiment, the opening or pocket may becreated using any of the techniques disclosed herein, includingexpandable balloons and hydrodissection.

Alternatively, the opening or pocket may be created during guide memberplacement by extending and retracting a blunt dissector on a guidemember placement device.

In yet another embodiment, the opening or pocket in which the sling isintroduced is created by the sling application catheter disclosed hereinafter the guide member is positioned.

Devices and methods for using a guide member to introduce a sling in thetissue between the urethra and the upper vaginal wall will now bediscussed in greater detail.

One aspect of the present invention relates to guide member placementdevices for applying a guide member under the urethra in a less invasivemanner without puncturing the vaginal wall.

In general, the guide member placement device comprises a shaft having aproximal end, a distal end, and a lumen extending therethrough. Thelumen is adapted for receiving a guide member.

Preferably, the shaft is rigid. It is also preferred that the proximalend of the shaft is attached to a handle having a lumen extendingtherethrough. Preferably, the guide member placement device has a bluntdissection tip with a lumen extending therethrough. The blunt dissectiontip is preferably located at the distal end of the shaft. It is alsopreferred that the blunt dissection tip is on a blunt dissector which iswithin the shaft and is extendable from and retractable in the shaft.

Preferably, the lumen in the blunt dissector is in fluid communicationwith the lumen in the handle. Preferably, the blunt dissector is axiallymovable and can be extended from and retracted in the shaft. Preferably,the blunt dissector is made of rigid plastic or flexible metal. Forexample, the blunt dissector may be a coil of stainless steel. The bluntdissector may be solid and may be made of metals such as stainlesssteel, spring steel, Elgiloy, Nitinol, or other generally elasticmetals. The blunt dissector may also be a rigid plastic such as nylon orAcrylonitrile Butadiene Styrene (ABS).

The guide member placement device has an engaging member at the distalend of the shaft which is complementary to or otherwise adapted to beattached to an engaging member at the distal end of the shaft of asecond guide member placement device, such that the shafts of the twoguide member placement devices can be attached to one another with thelumens of the blunt dissectors in each shaft in fluid communication withone another.

Referring to FIGS. 1, 2 and 3, there are disclosed guide memberplacement devices 10, 1910 in accordance with one aspect of the presentinvention. Handle 12, 1912 serves both as a gripping area for thephysician and as a support structure for the guide member placementdevice. Handle 12, 1912 preferably comprises a hollow tubular body 13,1913. The handle 12, 1912 is preferably of such a size to be easilygripped by a user. For instance, in one embodiment, the handle isapproximately 0.75 inches (20 mm) in diameter and approximately 4 inches(110 mm) in length. Preferably, handle 12, 1912 is provided withknurling or other surface texturing to produce a high friction grippingsurface.

A support 20, 1920 is preferably mounted such that it extends from thedistal end of the handle 12, 1912 to provide a mounting support for theshaft 22, 1922. The support 20, 1920 acts as a transition member fromthe handle 12, 1912 to support the shaft 22, 1922.

The shaft 22, 1922 is an elongate member with its proximal end insertedwithin or secured to the support 20, 1920. The shaft 22, 1922 may beattached to the support 20, 1920 in any variety of manners, includingbrazing, threading or other means well known to those of skill in theart.

The shaft 22, 1922 extends distally from the support 20, 1920 and ispreferably within the range of from about 6 inches to about 10 inches inlength.

The shaft 22, 1922 has a lumen 30 extending therethrough. A preferredembodiment of the distal end of the shaft is shown in FIGS. 7A and 7B.In this embodiment, the shaft 22, 1922 has a straight proximal section23, 1923, a bent intermediate section 25, 1925, and a distal end 27,1927. In an alternate embodiment, the shaft 2122, 2222 may be smoothlycurved as shown in FIGS. 7C and 7D. In the embodiments of FIGS. 7A-7D,the distal end of the shaft is preferably oriented at an angle of 90°relative to the straight proximal section of the shaft. Preferably, thecurve of the shaft is smooth to facilitate movement of the bluntdissector 32 within the shaft.

As will be understood by one of skill in the art, the dimensions andcurvature of the shaft 22, 1922 may vary depending on anatomicalconsiderations and the type of procedure in which it is intended to beused.

The distal ends 27, 1927 of the shafts 22, 1922 of the guide memberplacement devices 10, 1910 are provided with engaging members 28, 1928which are complementary to each other, such that the shafts 22, 1922 ofthe two guide member placement devices 10, 1910 are adapted to beattached to one another. In one embodiment of the guide member placementdevice 10, depicted in FIGS. 1 and 2, the engaging member comprises amale connector 17 as illustrated in the enlarged cross-sectional view ofFIG. 4. The male connector 17 on the guide member placement device 10shown in FIGS. 1 and 2 is complementary to the female connector 1915 onthe guide member placement device 1910 shown in FIG. 3 and shown in theenlarged cross-sectional view in FIG. 5. As shown in the enlargedcross-sectional view of FIG. 6, the male connector 17 on the guidemember placement device 10 of FIGS. 1, 2 and 4 engages the femaleconnector 1915 on the guide member placement device 1910 of FIGS. 3 and5 and attaches the two guide member placement devices 10, 1910 togethersuch that the lumens 42, 1942 of the blunt dissectors 32, 1932 of eachof the two devices are in fluid communication with one another. Whendesired, the male connector 17 disengages from the female connector1915, permitting the two guide member placement devices 10, 1910 to beseparated.

While the complementary engaging members 28, 1928 of the embodimentsshown in FIGS. 1-5 are male and female connectors, those skilled in theart will appreciate that a number of alternative configurations can beemployed for the engaging members, and the present inventioncontemplates such alternative configurations.

FIG. 2 is a cross-sectional view showing the internal structure of theguide member placement device 10 having a male connecter at the distalend of the shaft. The internal structure of the embodiment of the guidemember placement device 1910 having a female connector at the end of theshaft is similar to that shown in FIG. 2. Thus, the internal structurewill only be described with respect to the device having a maleconnector.

As shown in FIG. 2, the handle 12 has a proximal end wall 14 and adistal end wall 16. The support 20 as illustrated is provided with agenerally cylindrical proximal section 24 for engagement within thedistal end of the handle 12 and a tapered distal section 26 for securingthe shaft.

The shaft 22 is preferably no more than about 0.1 inches (2.5 mm) indiameter and is provided with at least one central lumen 30 foracceptance of an axially movable blunt dissector 32. The blunt dissector32 is mounted within the handle 12 and extends through the support 20and the shaft 22. The blunt dissector 32 is preferably provided at itsproximal end with a relatively large diameter body portion 34 adaptedfor reciprocal motion within tubular handle 12. Body portion 34 ispreferably provided with a slightly smaller diameter recessed portion 36for receiving a return spring 38 which biases the blunt dissector 32 inthe proximal direction and has a lumen 40 extending therethrough whichis in fluid communication with the lumen 42 of the narrow portion of theblunt dissector. Alternatively, any of a variety of well known means canbe utilized to provide a proximal bias on the blunt dissector 32.

The length of body portion 34 is less than the axial length of thecavity within handle portion so that the body portion 34 has an axialrange of motion within the range of from about 2 mm to about 10 mm, andpreferably about 0.12 inch (3 mm). The proximal end wall 44 of thesupport 20 which extends into the handle 12 acts as one limiting stopfor distal travel of body portion 34. The distal surface of the end wall14 of the handle limits proximal travel of body portion 34. Spring 38pushes against an' annular shoulder 46 on body portion 34, biasing theblunt dissector 3215 proximally.

The distal end of blunt dissector 32 is provided with a blunt dissectiontip 48 having a lumen therethrough. Spring 38 normally biases the bluntdissector 32 towards a first retracted position within the distal end ofshaft 22 such that the blunt dissection tip 48 does not extend from theshaft 22. Axial distal force on body portion 34 extends the bluntdissection tip 48 into a second position in which it extends from theshaft 22. Although the blunt dissection tip 48 may be extended andretracted in any number of ways, such as by use of a knob or button, itis preferred that a rotatable cam 50 be used.

The cam 50 is attached to a post 54 extending proximally from the handle12 and having a lumen 18 therein which is in fluid communication withthe lumen 40 in the recessed position of the blunt dissector and thelumen 42 in the narrow portion of the blunt dissector. The cam 50 isrotatably mounted about a pin 56 which extends along an axisperpendicular to the longitudinal axis of the shaft 22. The proximal endof the body portion has a rod 19 which extends proximally through anopening in the proximal end wall 14 of the handle.

The cam 50 has of least a two position engaging surface which, whenrotated into position, engages the rod 19 of the body portion. In afirst position, the cam 50 is biased by the return spring 38 to aposition in which the blunt dissection tip 48 is fully retracted withinthe shaft 22. In a second position, the bias imposed by return spring 38is overcome and engaging surface of the cam 50 engages the rod 19 suchthat the blunt dissection tip 48 is extended outwardly from the shaft22. The cam 50 is preferably provided with an actuator portion 58 whichextends radially outwardly and which may be used by the operator forrotating the cam.

Alternatively, other means such as pneumatic force generating means,hydraulic force generating means, piezoelectric force generating means,and electric force generating means may be used to overcome the bias ofthe spring and extend the blunt dissection tip 48.

It is preferred that this instrument be manufactured from a sterilizablematerial having sufficient rigidity for its intended purpose. Manyacceptable materials are well known in the art, such as stainless steelfor the shaft 22, and stainless steel or a plastic for the handleportion 12.

Alternatively, the guide member placement device may be made in adisposable form. In this embodiment, the components preferably are madeof a suitable thermoplastic. In particular, the thermoplastic Cyclolac2679F made by General Electric Plastics has been found suitable, whichis Acrylonitrile Butadiene Styrene (ABS). Preferably, the shaft 22,blunt dissector 32, and return spring 38 are made of stainless steel.

The use of the guide member placement devices of FIGS. 1-7D in arepresentative bladder neck stabilization procedure employing a sling isdescribed below and depicted in FIGS. 8-14. However, those skilled inthe art will appreciate that the guide member placement device may alsobe used in a number of other surgical procedures requiring introductionof a guide member.

The following procedure is intended to place a guide member in thetissue between the urethra and the vaginal wall without puncturing thevaginal wall. A Foley catheter is placed in the bladder to identify thebladder neck. The guide member placement device is percutaneouslyinserted into the body. For example, a pair of approximately one inchsuprapubic incisions 60 and 61, shown schematically in FIG. 9, may bemade over the pubic tubercles and dissection may be carried down to thearea of the rectus fascia. A first guide member placement device 10 isplaced within one of the incisions and advanced along the back side ofthe pubic bone so that the distal tip of the shaft 22 is in contact withthe bone/fascial surface to decrease the risk of puncturing the bladder.As resistance is felt, the cam 50 is pressed to extend the bluntdissection tip 48 from the distal end of the shaft 22, thereby creatingan opening in the body tissue 62 as shown in FIGS. 8 and 11. The cam 50is then released, retracting the blunt dissection tip 48 into the shaft22, and the device 10 is advanced through the opening in the bodytissue. This process results in the creation of a first opening in thebody tissue.

The first guide member placement device 10 is advanced until it ispositioned under the urethra 64 within the tissue 62 lying between theurethra 64 and the upper vaginal wall 66 as shown in FIG. 9. The bluntdissection tip 48 is extended and retracted during advancement of theguide member placement device 10 so as to create an opening in thetissue. Advancement of the guide member placement 10 device withextension and retraction of the blunt dissection tip 48 is continueduntil the distal end of the shaft 22 is positioned approximately midlineto the urethra 64 as shown in FIG. 10 such that the distal end of theshaft 22 extends transversely between the urethra 64 and the uppervaginal wall 66 in the plane defined by the longitudinal axes of theurethra and the vagina.

Alternatively, a pocket or opening in the tissue between the urethra andthe vagina may be created beneath the bladder neck prior to insertion ofthe first guide member placement device using the devices and methodsdescribed below. In this embodiment, the first guide member placementdevice 10 is advanced such that the distal end of the shaft is in thepocket or opening and the device is positioned as described above.

As the guide member placement device 10 is advanced, the elastic uppervaginal wall tents. This tenting can be utilized to determine theposition of the guide member placement device 10. The guide memberplacement device is advanced until tenting is apparent at the desiredlocation.

The above process is repeated with a second guide member placementdevice 1910 as shown in FIG. 12. The second guide member placementdevice 1910 has an engaging member 1928 complementary to that of thefirst guide member placement device 10 as shown in FIG. 6. The bluntdissection tip 1948 of the second guide member placement device 1910 isextended and retracted to create a second opening in the body tissue asdescribed above and shown in FIG. 11.

The second guide member placement device 1910 is advanced to a positionapproximately midline to the urethra 64 such that the distal end of theshaft 1922 extends transversely between the urethra 64 and the uppervaginal wall 66 in the plane defined by the longitudinal axes of theurethra and the vagina.

Alternatively, in the embodiment in which the pocket or opening in thetissue between the urethra and the vagina is created prior to insertionof the first guide member placement device, the second guide memberplacement device is advanced into the pocket or opening.

The second guide member placement device 1910 is then aligned with thefirst guide member placement device 10.

The first and second guide member placement devices 10 and 1910 are thenjoined through their engaging members 28, 1928, creating a continuousopening in the tissue 62 between the urethra 64 and the upper vaginalwall 66, as shown in FIG. 13. In an alternative embodiment, in additionto joining the two shafts, the two handles may also be coupled togetherand secured to one another.

After joining of the two guide member placement devices 10, 1910, thelumens 42, 1942 of the blunt dissectors are in fluid communication withone another, as shown in FIG. 6. As shown in FIGS. 13 and 2, a guidemember 68 is then inserted into the lumen 18 in the handle 12 of thefirst guide member placement device 10 and advanced through the lumens40, 1940, 42, 1942 of the blunt dissectors of the first and second guidemember placement devices 10, 1910 until it exits from the handle 1912 ofthe second guide member placement device.

The engaging members 28, 1928 of the two guide member placement devices10, 1910 are then disengaged from one another and the devices 10, 1910are removed from the patient's body, leaving the guide member 68 inplace, as shown in FIG. 14.

The guide member 68 may then be used to introduce a sling attached to asling application catheter in order to stabilize the bladder neck orstabilize the urethral floor as described in the following sections.

In alternative embodiments of the method, rather than using the bluntdissection tips 48 of the guide member placement devices to create thecontinuous opening in the tissue, the guide member placement device maybe inserted to a pre-formed opening in the tissue between the urethraand the upper vaginal wall. The pre-formed opening may be created byhydrodissection or with balloon catheters as described below. The stepsof this embodiment of the method are similar or identical to the methoddescribed above. However, if desired, this embodiment of the method canbe practiced with guide member placement devices having a bluntdissector which is fixed in a position in which it is extended from theshaft.

In an alternative embodiment of the method, the guide member placementdevice may be advanced through a trocar into the tissue between theurethra and the upper vaginal wall. In another embodiment, the guidemember placement device may be viewed laparoscopically during theprocedure to ensure proper positioning and assist in the alignment ofthe first and second guide member placement devices.

Sling Application Catheter

Another aspect of the present invention is a sling application catheterfor introducing a sling into an opening or pocket in the patient's bodytissue. In particular, the sling application catheter of the presentinvention can be used in urethral floor reconstruction procedures, suchas bladder neck stabilization procedures, to introduce a sling into thetissue between the urethra and the upper vaginal wall in a less invasivemanner than the techniques currently in use.

Generally, the sling application catheter comprises a catheter having asling therein which is releasably engaged with the catheter. Preferably,the sling is releasably engaged by a pouch in the catheter. Preferably,the sling application catheter is adapted to be guided along a guidemember. The guide member may be a suture, guide wire, or other structuresuitable for guiding the sling application catheter to a desiredlocation.

The sling application catheter may be attached to the guide member,suture, or other guiding device in numerous ways. For example, thecatheter may have a lumen extending therethrough through which the guidemember passes. The guide member may pass along the full length of thelumen, thereby extending entirely through the catheter. Alternatively,the guide member may extend partially through the lumen but exit thecatheter along its length through an opening in the wall of thecatheter.

In yet another embodiment, a loop with an aperture therein may beattached to the catheter. In this embodiment, the guide member passesthrough the loop to guide the catheter along the length of the guidemember. Those skilled in the art will appreciate that there are avariety of other ways to permit the sling application catheter to travelalong the guide member, and the present invention contemplates suchadditional approaches.

Preferably, the sling application catheter is long enough to spanbetween an insertion site in the patient's body and an exit site in thepatient's body. The insertion site and exit site are positioned oneither side of the location to which the sling is to be delivered.

The catheter may be a continuous cylinder with a lumen extendingtherethrough. Alternatively, the surface of the catheter may bepartially open with a slot therein which is narrower than the width ofthe guide member, suture or other guiding device. Preferably, the distalend of the catheter has a tapered tip to facilitate its passage throughthe body tissue.

The pouch permits the sling to be handled without damage, maintains abarrier preventing microorganisms from contacting the sling, provideshandling flexibility, and ensures that the sling is introduced into theopening or pocket in the patient's body tissue in the desiredorientation. The pouch may be made of a variety of materials such aspolyethylene terephthalate (PET), polyethylene (PE), vinyl, polyesterand ethylene vinyl acetate (EVA). Preferably, the pouch is made of PET.

Preferably, the pouch is flat to facilitate delivery of the sling in aflat orientation. However, the pouch may also be conical, or rolledconical, and be provided with means for flattening the sling afterdelivery. Alternatively, the sling application catheter may be used inconjunction with slings made from materials which adopt a flatconfiguration after delivery.

Preferably, the pouch is clear or translucent to permit visualization ofthe sling within. In some embodiments, the pouch is made of a porousmaterial such as polyethylene, polyethylene terephthalate or vinyl. Inone embodiment, the pouch is adapted to receive a sling long enough topass between a first suprapubic incision on one side of the urethra anda second suprapubic incision on the opposite side of the urethra.

In an alternative embodiment, the pouch may be adapted to receive asling having a shorter length than the slings used with the embodimentdescribed above. Such slings are attached to the pubic bone by sutures.

Long and short slings suitable for use with the present invention aredescribed in U.S. patent application Ser. No. 09/023,398, entitled“Stabilization Sling for Use in Minimally Invasive Pelvic Surgery”(VESITEC.023A), filed Feb. 13, 1998, now issued U.S. Pat. No. 6,042,534,issued Mar. 28, 2000, and the identically titled U.S. Provisional PatentApplication Ser. No. 60/038,379, filed Feb. 13, 1997, the disclosures ofwhich are incorporated herein by reference.

The length of the pouch may be varied depending upon the length of thesling with which the sling application catheter is to be used.

One embodiment of a sling application catheter 210 according to thepresent invention is shown in FIGS. 15 and 16. The sling applicationcatheter of FIG. 15 comprises a catheter 212 and a pouch 214 adapted toreleasably engage a sling 216 attached thereto. The distal end 218 ofthe catheter is tapered and extends beyond the distal end 220 of thepouch. The distal end 220 of the pouch is also tapered to facilitate itspassage through the patient's body tissue. A lumen 222 extends throughthe catheter.

A cross section of the sling application catheter 210 of FIG. 15 with asling 216 inside the pouch 214 is shown in FIG. 17. The sling 216depicted in FIG. 15 is sufficiently long to pass between two suprapubicincisions on opposite sides of the urethra. Preferably, the sling 216extends beyond the proximal end 224 of the pouch of the slingapplication catheter to permit the proximal end 226 of the sling to begrasped or secured.

Alternatively, shorter slings which are attached to the pubic bone viasutures may be used. The sling 216 may have sutures or integralattachment members extending bilaterally therefrom. Long and shortslings suitable for use with the present invention are disclosed in U.S.patent application Ser. No. 09/023,398, entitled “Stabilization Slingfor Use in Minimally Invasive Pelvic Surgery” (VESITEC.023A), filed Feb.13, 1998, now issued U.S. Pat. No. 6,042,534, issued Mar. 28, 2000, andthe identically titled U.S. Provisional Patent Application Ser. No.60/038,379, filed Feb. 13, 1997, the disclosures of which areincorporated herein by reference. In such an arrangement, a suture orintegral attachment member extends beyond the proximal end 224 of thepouch and can be grasped or secured by the physician to withdraw thesling from the pouch.

As illustrated in FIGS. 18 and 19, in alternative embodiments of thesling application catheter 310, the pouch 314 has a reinforcingstiffener 328. The reinforcing stiffener 328 may be on the interior orthe exterior of the pouch 314. The stiffener 328 provides rigidity andprevents distortion of the sling 316 during passage through thepatient's body tissue, as well as permitting the sling applicationcatheter 310 to dilate or tear an opening in the patient's body tissueas it passes therethrough. In this manner, the sling applicationcatheter 310 may be used to create an opening in the tissue between theurethra and the upper vaginal wall in which the sling is introduced. Thestiffener 328 may also provide a bending effect which permits the slingto follow an axial bend along its width. Finally, the stiffener 328reduces damage to the sling material during handling.

The stiffener 328 may be made of any of a variety of materialscompatible with the above described considerations such as polyethylene,polypropylene, or acrylic. Preferably, the stiffener 328 providesapproximately a 1 cm radius of bending.

In some embodiments, the stiffener 328 is made of a porous material suchas polyethylene or polyethylene terephthalate having pores which permita solution to access the sling during a soak as described below.

Preferably, the sling 216 introduced into the opening in the patient'sbody is sterile. In this regard, FIG. 20 depicts a further embodiment ofthe sling application catheter 410, in which the pouch 414 has pores 411to permit rehydration of slings made of natural materials and antibioticor saline soaks of the sling in the pouch prior to introduction of thesling into the patient. In this embodiment, the pouch 414 may be made ofa variety of materials, such as PE, PET or vinyl. Preferably, the porousmaterial has pore sizes ranging from about 100 microns to about 0.25inches. Preferably, the pouch 414 is made of vinyl having a pore size of0.125 inches.

The sling application catheters described above may be used in a varietyof procedures in which delivery of a sling to an opening or pocket inthe patient's body tissue is desired. A representative method in whichthe sling application catheter of FIGS. 15-20 are used to deliver asling in a bladder neck stabilization procedure is described below anddepicted in FIGS. 21-23. While the procedure is described withparticular reference to the sling application catheter 210 of FIG. 15,those skilled in the art will appreciate that the sling applicationcatheters 310, 410 of FIGS. 18 and 20 may also be used in the procedure.

A guide member 68 is introduced into the tissue between the urethra andthe upper vaginal wall using a device such as the guide member placementdevices 10, 1910 described above. As illustrated in FIG. 21, the guidemember extends between two suprapubic incisions 61 and 62 on oppositesides of the urethra 64. As shown in FIG. 21, the end of the guidemember 68 extending from the first suprapubic incision 60 in thepatient's body is inserted into the lumen 222 of the catheter 212 suchthat the guide member passes 68 entirely through the catheter 212. Asling 216 capable of passing beneath the urethra and through theabdominal tissue on opposite sides of the urethra 64 is inserted intothe pouch 214 such that the proximal end 226 of the sling extends fromthe proximal end 224 of the pouch.

Alternatively, a shorter sling 216 may be used. Such shorter slings maybe attached to the pubic bone by sutures. In this embodiment, the slingmay have sutures or integral attachment members extending bilaterallyand may be inserted into the pouch so that a suture or integralattachment member extends from the proximal end of the pouch.

Long and short slings suitable for use with the sling applicationcatheter are described in U.S. patent application Ser. No. 09/023,398,entitled “Stabilization Sling for Use in Minimally Invasive PelvicSurgery” (VESITEC.023A), filed Feb. 13, 1998, now issued U.S. Pat. No.6,042,534, issued Mar. 28, 2000, and the identically titled U.S.Provisional Patent Application Ser. No. 60/038,379, filed Feb. 13, 1997,the disclosures of which are incorporated herein by reference.

The physician percutaneously inserts the sling application catheter andadvances it along the guide member. For example, the sling applicationcatheter may be inserted through a first suprapubic incision 60. As thepouch 214 passes beneath the urethra 64, the physician grasps theportion of the sling or the suture or integral attachment memberextending from the proximal end of the pouch while continuing to advancethe sling application catheter 210, causing the sling 216 to bewithdrawn from the pouch 214 as illustrated in FIG. 22. The slingapplication catheter is advanced until it exits the patient's body at asecond suprapubic incision 61, leaving the sling extending between thefirst 60 and second 61 incisions as shown in FIG. 23.

Alternatively, when the shorter slings are used, the sutures or integralattachment members extend from the first and second incisions.

Following the completion of the preceding procedures, the sling 216 islocated in the tissue 62 between the urethra and the upper vaginal wall.

Following implantation, the sling or sutures or integral attachmentmembers extending therefrom may be sewn, stapled, riveted, or anchoredto any of a variety of structures, such as the pubic bone, Cooper'sligament or rectus fascia to stabilize or stabilize the bladder neck orto stabilize the pelvic floor. For example, the long sling may beattached directly to the pubic periosteum using staples, clips, orsutures or may be attached to the pubic bone with short sutures attachedto a bone anchor implanted in the pubic bone or fastened to the pubicbone with a headed nail or screw-like anchoring device.

The slings may be used to stabilize the bladder neck as described inU.S. patent application Ser. No. 09/023,398, entitled “StabilizationSling for Use in Minimally Invasive Pelvic Surgery” (VESITEC.023A),filed Feb. 13, 1998, now issued U.S. Pat. No. 6,042,534, issued Mar. 28,2000, and the identically titled U.S. Provisional Patent ApplicationSer. No. 60/038,379, filed Feb. 13, 1997. The tension on the sling maybe adjusted as appropriate, using approaches such as those described inU.S. Pat. No. 5,611,515, issued Mar. 18, 1997 to Benderev et al., thedisclosure of which is incorporated herein by reference, to support thebladder neck or stabilize the urethral floor, thereby maintaining orimproving urinary continence.

Tissue Dissector/Dilator

Another aspect of the present invention is a tissue dissector/dilator510 for creating an opening or pocket in a body tissue and dilating theopening or pocket with an expandable dilator. The tissuedissector/dilator finds particular application in urethral floorreconstruction procedures, such as bladder neck stabilization proceduresin which the tissue between the female urethra and the upper vaginalwall is dissected and dilated to facilitate placement of a therapeuticsling device designed to alleviate incontinence.

The tissue dissector/dilator can be used in percutaneous approaches inwhich the sling is introduced into an opening or pocket in the tissuebetween the urethra and the upper vaginal wall without entry of thevaginal canal. Such procedures are described in detail below.

The tissue dissector/dilator generally comprises a body with anon-compliant shaft attached thereto. Preferably, the shaft has at leastone lumen extending therethrough.

A dissector for creating an opening or pocket in the body tissue iscarried on the shaft. The dissector may be on the exterior of the shaftor in the interior. Preferably, the dissector is within the lumen of theshaft and is axially movable such that it is capable of being extendedfrom and retracted in the shaft to create an opening in the body tissue.

A dilator for dilating the opening or pocket is also carried on theshaft. The dilator may be on the exterior of the shaft or in theinterior. Preferably, the dilator is within the lumen of the shaft andis axially movable such that it is capable of being extended from andretracted in the shaft. Preferably, the dilator is expandable andcollapsible.

Preferably, the dissector and the dilator are integral. Alternatively,the movable dissector and the dilator can be separate elements of thetissue dissector/dilator. Preferably, both the dissector and the dilatorare axially movable.

In yet another embodiment, the dissector and the dilator are notintegral parts of the tissue dissector/dilator. In this embodiment, thedissector and the dilator are distinct devices which can be insertedinto the shaft of the tissue dissector/dilator at the point in thesurgical procedure in which tissue dissection or dilation is required.

A representative embodiment of the tissue dissector/dilator 510 is shownin FIG. 24. As shown in FIG. 24 the body 512 comprises a trigger 514, alocking wheel 516, and a spring return button 518. In the embodiment ofFIG. 24, the trigger 514 and the upper section 520 of the body each havea slot 522 and 524 therein which together define an aperture 526 adaptedto receive a syringe 528 therein. However, those skilled in the art willappreciate that the body 512 can have a number of configurationscompatible with the intended use of the-tissue dissector/dilator and thepresent invention encompasses such additional configurations.

The spring return button 518 can slide along a slot in a vertical faceof the body. As shown in FIG. 24, the spring return button 518 is biasedtowards a first position at the proximal end of the slot by a spring. Asshown in FIG. 25, the spring return button 518 can slide to a secondposition in which it is locked in place. As illustrated in FIG. 25, inthe locked position, the spring return button 518 fits into a groove onthe body 512 and is located on a face of the body perpendicular to theface on which the spring return button 518 is located in the unlockedstate.

The spring return button 518 may have an internal extension inside thebody which has a proximal section adapted to receive a syringe tip.

As illustrated in FIG. 24, the shaft 530 is attached to the bottomportion 532 of the body 512 and has a lumen extending therethrough. Theshaft 530 may be fabricated from a number of non-compliant materialssturdy enough to resist torque applied while the device is advancedthrough the body tissue. Preferably the shaft 530 is made of stainlesssteel.

Preferably, the shaft 530 curves towards its distal end 534. Preferably,the curve is a small radius curve. Preferably, the distal end 534 of theshaft is at an angle of about 90° relative to the proximal portion ofthe shaft. However, those skilled in the art will appreciate that thecurve in the shaft 530 may vary depending on anatomical considerationsand the type of procedure in which the tissue dissector/dilator is to beused.

As shown in FIG. 25, a balloon catheter 536 is located within the lumenof the shaft 530 and is engaged by the spring return button 518. Asillustrated in FIG. 26, the balloon catheter 536 comprises an outer tube538 having a lumen extending therethrough and an expandable balloon 540in the lumen of the outer tube 538. An inflation tube 542 with a lumentherein is located at the proximal end 544 of the expandable balloon andis in fluid communication with the interior of the balloon 540.Preferably, the expandable balloon 540 has a blunt dissection tip 546 atits distal end 548.

The inflation tube 542 may be made of any of a number of materials, suchas PE or PET. Preferably, the inflation tube 542 is made of anon-compliant or minimally compliant material.

In the embodiment of FIG. 26, the expandable balloon 540 has acylindrical shape when expanded. Preferably, the dimensions of theballoon are adapted for dilating an opening or pocket in the tissuebetween the urethra and the upper vaginal wall. The length of theballoon is dependent upon the direction in which it is oriented relativeto the urethra in the procedure being used to create the pocket oropening. When the balloon is oriented perpendicular to the urethra theballoon is preferably 4-6 cm in length, with an effective width of 2 cmto create a pocket or opening of approximately 5 cm in length and 2 cmin width.

When used in procedures in which the balloon is oriented parallel to theurethra the balloon may be shorter than those used in procedures inwhich the balloon is perpendicular to the urethra. Balloons used in suchprocedures may also have a larger diameter than those used in proceduresin which the balloon is perpendicular to the urethra. Balloon cathetershaving a plurality of balloons side by side or flat profile balloons,such as those described in more detail below, are also well suited forsuch procedures.

Preferably, the balloon expands radially but does not increase in lengthwhen 30 expanded.

The blunt dissection tip 546 is preferably cylindrical in shape.Preferably, the blunt dissection tip 546 is about ¼ inch in length.

The blunt dissection tip 546 may be fabricated from a variety ofmaterials which are rigid enough to facilitate their use in bluntdissection of a body tissue. The tip of the balloon may be formed into asolid tip which functions as the blunt dissection tip. Alternatively,the blunt dissection tip 546 may comprise the same material as theinflation tube 542. In yet another embodiment, the blunt dissection tipmay be stainless steel.

The balloon catheter may also have a second lumen therein for receivinga guide member. In this embodiment, a guide member may be placed throughthe aperture in the body, pass through the shaft, and extend out of thedistal tip of the shaft, permitting the tissue dissector/dilator to beused to place a guide member in the opening or pocket created in thebody tissue. The guide member may be a suture, guide wire, or otherstructure suitable for guiding a sling to a desired location.

In another embodiment, the balloon catheter may have a third lumentherein for irrigation or for receiving diagnostics, such as anultrasound catheter. The third lumen may also be used for passage of animplant, such as fibrin glue or a bladder neck suspension orstabilization sling, such as those described in U.S. patent applicationSer. No. 09/023,398, entitled “Stabilization Sling for Use in MinimallyInvasive Pelvic Surgery” (VESITEC.023A), filed Feb. 13, 1998, now issuedU.S. Pat. No. 6,042,534, issued Mar. 28, 2000, and the identicallytitled U.S. Provisional Patent Application Ser. No. 60/038,379, filedFeb. 13, 1997, the disclosures of which are incorporated herein byreference.

As shown in FIG. 24, when the spring return button 518 is positioned atthe most proximal point of its path in the vertical face of the body512, the balloon catheter 536, including the blunt tip 546 and theexpandable balloon 540, is retracted within inside the shaft 530. Asillustrated in FIG. 27, when the spring return button 518 is movedtowards the distal end of the slot, force is communicated to the ballooncatheter 536 causing it to move axially towards the distal end 534 ofthe shaft, such that the blunt dissection tip 546 extends out of theshaft 530. If the spring return button 518 is then released, the biasfrom the spring will cause the spring return button 518 to return to themost proximal point of the slot, thereby returning the blunt dissectiontip 546 to a fully retracted position within the shaft 530. Preferably,the spring return button 518 provides a one to one stroke motion to theblunt dissection tip 546. When the spring return button 518 is locked atits most distal position, the expandable balloon 540 and the bluntdissection tip 546 protrude from the distal end 534 of the shaft, asshown in FIG. 25.

As shown in FIG. 24, the proximal end of the body is adapted to receivea syringe 528 therein. The syringe 528 comprises a plunger 550, areservoir, and a tip. The tip of the syringe engages the proximalsection of an internal extension of the spring return button 518. Asillustrated in FIG. 25, when the spring return button 518 is placed inthe locked position, the syringe 528 moves into the body 512 and ispositioned so as to permit the plunger 550 to engage the trigger 514.The tip of the syringe contacts the locking wheel 516 and engages a luerconnection thereon. When the locking wheel 516 is tightened, the syringe528 is firmly fixed in place such that the reservoir of the syringe isin fluid communication with the lumen of the balloon catheter.

With the spring return button 518 in the locked position, the plunger550 of the syringe engages the trigger 514, such that squeezing thetrigger 514 causes the plunger 550 of the syringe to be depressed. Whenthe reservoir of the syringe is filled with a fluid, such as sterilesaline or sterile water, squeezing the trigger 514 causes the fluid tobe dispensed from the syringe 528 into the lumen of the inflation tube542, thereby inflating the expandable balloon as illustrated in FIG. 28.The trigger 514 contains a return spring, such that when the trigger 514is released from the squeezed position, the trigger returns to itsoriginal position, drawing the plunger 550 of the syringe upward andthereby creating a vacuum in the syringe reservoir which draws the fluidfrom the expandable balloon 540 and deflates the balloon. The plunger550 and the trigger 514 may be interconnected through a variety ofstructures familiar to those skilled in the art. For example, they maybe interconnected through a rack and pinion gear.

An alternative embodiment of the tissue dissector/dilator 610 is shownin FIG. 29. In this device, the trigger 654 has an alternate shape asshown in FIG. 29 and engages a set of teeth 652 on the plunger 650 ofthe syringe. The body has a central aperture 626 therein which receivesthe syringe. Additionally, in this embodiment the locked position of thespring return button 618 is close to the bottom of the body 612 and thespring return button 618 is on the same face of the body in its lockedand unlocked states.

While several embodiments of the tissue dissector/dilator have beendescribed above, those skilled in the art will appreciate thatalternative configurations are compatible with the function of thedevice. Such additional configurations are within the scope of thisinvention.

The following section describes the use of the tissue dissector/dilatorin the context of a percutaneous bladder neck stabilization orsuspension procedure in which a sling is utilized for treating urinaryincontinence in females. However, those skilled in the art willrecognize that the tissue dissector/dilator may also find application ina variety of other procedures in which it is necessary to introduce anopening into a body tissue and subsequently dilate that opening. Whilethe procedure is described with particular reference to the tissuedissector/dilator 510 shown in FIGS. 24, 25, 27 and 28, those skilled inthe art will appreciate that the tissue dissector/dilator 610 shown inFIG. 29 may also be used in the procedure.

The shaft of the tissue dissector/dilator is inserted percutaneously.For example, percutaneous insertion may be through a one inch transverseincision made over a pubic tubercle with dissection is carried down tothe area of the rectus fascia. The tissue dissector/dilator 510, 610 isguided through the patient's body tissue along the back side of thepubic bone while maintaining the distal end of the shaft in contact withthe pubic bone. If resistance is encountered while advancing the tissuedissector/dilator through tissue, the spring return button 518 may berepetitively partially depressed and allowed to return to its mostproximal position through the action of the biasing spring. This processresults in repetitive extension of the blunt dissection tip 546 out ofthe shaft 530 and retraction of the blunt dissection tip 546 back intothe shaft 530, thereby dissecting an opening in the body tissue throughwhich the device is passing.

The tissue dissector/dilator 510 is advanced until tenting is observedon the upper vaginal wall. As shown in FIG. 30, the user thenmanipulates the distal end of the shaft 534 until it intersects thetissue 62 between the urethra 64 and the upper vaginal wall 66 atapproximately mid-thickness and in a direction which would permit theexpandable balloon to advance perpendicular to the axial direction ofthe urethra.

As illustrated in FIG. 31, the tissue 62 between the urethra 64 and theupper vaginal wall 66 is then blunt dissected by repetitively extendingand retracting the blunt dissection tip 546 using the spring returnbutton 518 as described above, thereby creating an opening in thetissue. The dissection process is repeated until an opening is createdin the tissue 62 which is large enough to permit the expandable balloon540 to be fully extended from the shaft 530 such that the distal end ofthe shaft extends transversely between the urethra 64 and the uppervaginal wall 66 in the plane defined by the longitudinal axes of theurethra and the vagina, as shown in FIG. 32.

The spring return button 518 is advanced to its locked position in whichthe expandable balloon 540 is fully extended into the opening in thebody tissue, as shown in FIG. 32. The syringe 528 is locked in placesuch that its reservoir is in fluid communication with the lumen of theinflation tube 542 of the balloon catheter 536 and its plunger 550engages the trigger 514. The trigger 514 is squeezed to dispense thesaline solution inside the reservoir of the syringe through theinflation tube 542 of the balloon catheter 536 and into the expandableballoon 540, causing the balloon 540 to expand. Expansion of the balloon540 dilates the body tissue, creating a first opening therein as shownin FIG. 33.

The trigger 514 is then released and is returned to its originalposition through the action of the return spring. As the trigger returnsto its original position, a vacuum is created in the reservoir of thesyringe 528, thereby drawing the fluid out of the expandable balloon 540and causing the balloon 540 to deflate.

The trigger 514 can be squeezed and released multiple times, ifnecessary, until the opening in the body tissue expands. The expandableballoon 540 and blunt dissection tip 546 are then retracted into theshaft 530.

The above dissection and expansion steps can be repeated while advancingthe tissue dissector/dilator through the tissue between the urethra andthe upper vaginal wall, as shown in FIGS. 34-36. The dissection andexpansion steps may be repeated until a continuous dilated opening orpocket 11 exists in the tissue 62, as shown in FIG. 37. Following thecreation of the continuous dilated opening or pocket, the tissuedissector/dilator is removed from the patient's body.

Alternatively, the continuous dilated opening or pocket 11 can becreated from both sides of the urethra. In this procedure, a firsttissue dissector/dilator is advanced approximately to the midline of theurethra while dissecting and expanding the tissue 62 as described aboveto create a first opening in the body tissue. The first tissuedissector/dilator may be removed from the body, or, in the embodimentsdescribed below in which two tissue dissector/dilators areinterconnected to pass a guide member or suture through the patient'sbody, the first tissue dissector/dilator may remain in the patient'sbody.

A second tissue dissector is percutaneously inserted. This may beaccomplished through a second suprapubic incision made on the oppositeside of the urethra from the first suprapubic incision. A second tissuedissector/dilator 510 is inserted into the second incision and advancedthrough the body tissue until it is aligned with the first opening inthe body tissue. Correct alignment of the second tissuedissector/dilator with the first opening in the body tissue isdetermined through visualization of tenting of the vaginal wall andthrough tactile sensation. The blunt dissector tip 546 of the secondtissue dissector/dilator 510 is extended and retracted from the shaft530, thereby creating a second opening in the body tissue which isjoined to the first opening in the body tissue. The expandable balloon540 is extended into the second opening and expanded within the secondopening, thereby dilating the body tissue. When the second tissuedissector/dilator 510 is removed from the patient's body a continuousdilated opening or pocket 11 exists in the tissue 62, as shown in FIG.37.

In both of the above methods, a sling may be introduced into the openingor pocket using the sling application devices described herein tosuspend or stabilize the pelvic floor.

In the embodiment in which the balloon catheter has a second lumen forreceiving a guide member, the tissue dissector/dilator may be used tointroduce a guide member as follows. After creation of the first openingor pocket but before removal of the first tissue dissector/dilator fromthe body, a guide member, suture, guide catheter, or webbing isintroduced into the second lumen of the catheter. When the first tissuedissector/dilator is removed from the body, the guide member is left inplace.

After creation of the continuous pocket but before removal of the secondtissue dissector/dilator from the body, the guide member in the firstpocket is introduced into the second lumen of the catheter of the secondtissue dissection/dilator and advanced therethrough. When the secondtissue dissector/dilator is removed from the body after creation of thecontinuous pocket, the guide member remains in place and extends betweenboth suprapubic incisions, passing under the urethra and through thecontinuous pocket. Alternatively, the tissue dissector/dilator may havean engaging member at the distal end of the shaft, permitting twodevices to be interconnected with their lumens in fluid communication asdescribed above for the guide member placement device. In thisembodiment, the guide member, suture, guide catheter, or webbing ispassed through the interconnected lumens of the first and second tissuedissector/dilators as described above in regard to the guide memberplacement device. Thus the guide member, suture, guide catheter orwebbing extends between the two suprapubic incisions and passes throughthe tissue between the urethra and the upper vaginal wall.

The guide member can then be used to introduce a sling into the openingor pocket as described above.

In yet another embodiment, the tissue dissector/dilator may be used intransvaginal procedures. For example, the tissue dissector/dilator maybe inserted through the upper vaginal wall rather than throughsuprapubic incisions. In this embodiment the device is advanced into thetissue 62 between the urethra and the upper vaginal wall and the balloonis expanded to create an opening or pocket as described above.

Sling Application Device and Sling Application System

Another aspect of the present invention is a sling application devicefor inserting a sling into an opening or pocket in a body tissue. Thesling application device provides access to the tissue between theurethra and the upper vaginal wall and introduces a sling into a pocketor opening in that tissue. In some embodiments, the sling applicationdevice creates the pocket or opening into which the sling is inserted.In other embodiments, the sling application device introduces the slinginto a pre-formed pocket or opening. The device may be used inpercutaneous methods alone or in laparoscopic procedures.

Another sling application device for introducing a sling into the tissuebetween the urethra and the upper vaginal wall is currently available.This device comprises two shafts, each having a central lumen, which canbe clamped together via horizontally extending tabs present at theproximal end of each shaft. Rotation of a lever on one of the horizontaltabs clamps the two tabs together, thereby locking the two shafts to oneanother.

The currently available device is used to introduce a sling into thetissue between the urethra and the upper vaginal wall as follows. Thetwo shafts are introduced into incisions on opposite sides of theurethra in the unlocked configuration. The shafts are advanced throughthe patient's tissue until they are located underneath the urethra withthe lumens of the two shafts aligned. The lever is then rotated to thelocked position, fixing the two shafts together. A sharp blade isinserted through the lumen of one of the two shafts such that itcontacts the tissue between the distal ends of the shafts. As the bladeis advanced through the tissue between the distal ends of the shafts,the tissue is dissected. Eventually, the blade enters the lumen of thesecond shaft, thereby creating a continuous opening in the tissuebetween the urethra and the upper vaginal wall.

The two shafts are unlocked and one of them is removed from thepatient's body. A suture is inserted into the eye of the blade and theblade is advanced into the opening in the tissue between the urethra andthe upper vaginal wall. A right angle clamp is then used to grasp andfollow the suture into the tissue between the urethra and the uppervaginal wall. When the jaws of the right angle clamp are spread, anenlarged opening sized to receive a sling is created. The sling is thenguided along the suture and introduced into the enlarged opening.

As will be apparent from the following description, the present slingapplication device provides several advantages over the currentlyavailable device. For example, the present device eliminates the use ofa right angle clamp to create the sling receiving opening which isrequired with the currently available device. Moreover, the slingintroducer permits the sling application device to introduce the slingwithout the use of a guiding suture as required with the currentlyavailable device. A further advantage of the present device and methodsfor using the device is that when the pocket or opening is created byhydrodissection the procedure can be performed without cutting thetissue between the two shafts of the sling application device.Furthermore, with the present device, it is not necessary to seat thedistal ends of the shaft together before locking the two halves of thedevice to one another.

The present sling application device generally comprises a first and asecond shaft. The first and second shafts have a central lumen which issized to allow a sling to advance therethrough. The lumens of the firstand second shafts may also be sized to allow a sling introducer to passtherethrough. Preferably, the shafts of the present sling applicationdevice are sufficiently wide to create or maintain an opening in thetissue capable of receiving the sling.

Preferably, the sling application device further comprises a firsthandle attached to the first shaft and a second handle attached to thesecond shaft. The first and second handles have openings therein whichare in fluid communication with the lumens in the shafts to which thehandles are attached. Preferably, the first and second handles areadapted to be connected to one another.

The present sling application device includes an adjuster forincrementally adjusting the distance between the distal ends of thefirst and second shafts. The adjuster allows the distance between thedistal ends of the shafts to be slowly decreased while monitoring thepatient to ensure that the urethra is not pinched during the procedure.This feature is absent from the currently available device, which hasonly two configurations, the locked and unlocked configurationsdescribed above. Preferably, the adjuster engages the first and secondhandles.

Preferably, the upper portions of the distal ends of the first andsecond shafts are indented relative to the lower portions of the distalends to reduce the possibility of pinching of the urethra during thesling implantation procedure. This feature is absent from the currentlyavailable device, increasing the risk of damage to the urethra when thatdevice is used.

The shafts of the present sling application devices are adapted toreceive several components during the sling application procedure suchthat the sling application device can be used as part of a slingintroduction system. The sling introduction system generally comprisesthe sling application device, a blunt dissector and a sling introducer.In some embodiments, the sling introduction system may further comprisea sharp tissue cutter.

A representative embodiment of the sling application device 710 is shownin FIG. 38A. As shown in FIG. 38A, the sling application device 710comprises a first handle 712 and a second handle 714, having first 716and second 718 shafts, respectively, attached thereto. The first andsecond handles have openings 725, 727 and therein which are adapted toreceive a sling or sling introducer. The first and second shafts 716,718 are adapted for insertion into a body tissue and have central lumens711 and 713, respectively, which extend therethrough. The lumens offirst and second shafts are in fluid communication with the openings inthe first and second handles and are adapted to receive a sling or slingintroducer. The first and second shafts 716, 718 have dimensions adaptedfor creating or maintaining a pocket or opening in the body tissue andfor receiving a sling introducer. The sling application device alsocomprises an adjuster 720 for adjusting the distance between the firstshaft 716 and the second shaft 718. Preferably, the adjuster 720 is anarticulating lock. As shown in FIG. 38A, the first handle 712 has agenerally rectangular distal portion 722, an indented region 724, and agenerally rectangular proximal portion 726 having a width less than thewidth of the generally rectangular distal portion 722. One face of thefirst handle 712 has a rectangular recess 728 open at each end forreceiving an extension 730 on the second handle.

As shown in FIG. 3813, the first handle has a locking button 732 with atab 717 thereon which is adapted to engage a groove 734 in the extension730 section which is disposed between the first handle 712 and thesecond handle 714, thereby locking the two handles together. Alignmentof the first handle 712 with the second handle 714 during locking isachieved by placing alignment pin 756 in alignment hole 758. However,those skilled in the art will appreciate that other means for aligningthe handles and locking them together may also be used.

A first shaft 716 with a central lumen therethrough extends through thefirst handle 712. As shown in FIGS. 39, 40 and 41, the first shaft 716is cylindrical and curves toward its distal end 736. The first shaft 716may be from about 3 inches to about 10 inches in length, with an outerdiameter from about 3/16 inch to about ⅝ inch with a wall thickness fromabout 0.010 inch to about 0.020 inch. Preferably, the first shaft 716 isfrom about 6 inches to about 8 inches in length, with an outer diameterfrom about 0.187 inch to about 0.275 inch. However, those skilled in theart will appreciate that the preceding dimensions may vary depending onahatornical considerations and the type of procedure being performed.

The first shaft 716 may be made of a variety of materials, includingstainless steel and aluminum. Preferably, the first shaft 716 is madefrom stainless steel.

The first shaft 716 is curved near its distal end. Preferably, the firstshaft 716 curves through an arc from about 80° to about 90°. Morepreferably, the first shaft 716 curves through an arc of about 90°.

In an alternate embodiment of the sling application device 810, shown inFIGS. 42, 43 and 44, the portion of the first shaft 816 proximal to thecurve is cylindrical and the portion of the first shaft 816 distal tothe curve is a flat tube. The flat tube may have a variety of crosssectional shapes such as rectangular, hexagonal or oval. The first shaft816 is curved as described above for the embodiment in which the shaftis cylindrical.

In a further embodiment of the sling application device 910, the firstshaft 916 comprises a tube which is flat along its entire length asshown in FIGS. 45 and 46. The first shaft 916 is curved towards itsdistal end as described above for the embodiment in which the shaft iscylindrical.

Preferably, the first shaft has a side bend. In accordance with thisembodiment, the first shaft can be flat, cylindrical, or flat in someportions and cylindrical in others as described above with respect tothe sling application devices 710, 810, 910 discussed above.

FIGS. 47, 47A and 47B show a sling application device 1010 in which theshafts have a side bend. In this embodiment, the first shaft 1016 isflat and has a first curved section 1021 and a second curved 1023section along its length. Preferably, the portion maximum offset betweenthe first curved section 1021 and the second curved section 1023 is fromabout 1 inch to about 3 inches. As shown in FIGS. 47 and 47B, the secondshaft 1018 has the same structure as the first shaft 1016. Preferably,the first and second shafts 1016, 1018 undergo a smooth transition fromcylindrical to elliptical or flat. More preferably, the portion of theshaft proximal to the first curved section 1021 is cylindrical and theportion of the shaft distal to the first curved section is flat.Preferably, the radius of curvature of the second curve is not planarwith the axial plane of the portion of the shaft. The adjuster 1020 inthis embodiment may be the same as the adjuster described above.

Alternatively, the shaft may have a 90° twist as shown in FIG. 48. Inthis embodiment of the sling application device 1910, the proximalportion 1929 of the first shaft 1916 is oriented at an angle of 90°relative to the distal portion 1931 of the first shaft, with atransitional section 1933 disposed between the proximal section of thefirst shaft 1929 and the distal section of the first shaft 1931. Theadjuster 1920 in this embodiment may be the same as the adjusterdescribed above.

Referring to FIG. 38A, one face 746 of the second handle is adapted toenable the physician to firmly grasp it when advancing the devicethrough tissue. An adjuster 720 is slidably mounted on face 746. Theadjuster 720 slidably engages a guide 748 on the bottom of the firsthandle 712. The guide 748 is hingedly connected to the extension 730 andis biased away from the extension 730 by a biasing means such as aspring 754 (indicated in FIG. 56) disposed between the guide 748 and theextension 730. Tabs 750 on the adjuster 720 fit into grooves 752 betweenthe sides of the extension 730 and the sides of the guide 748 such thatthe adjuster 720 moves along the guide 748 between a proximal end and adistal end. When the two handles have been locked together, moving theadjuster 720 along the guide 748 adjusts the distance between the distalends of the first and second shafts 716, 718 as depicted in FIGS. 56-58,which are discussed in greater detail below. However, those skilled inthe art will appreciate that there are other adjuster designs compatiblewith the operation of the present device, and such designs arespecifically contemplated in the present invention.

As the adjuster 720 is moved towards the distal extreme of the guide748, the resistance of the spring biasing the guide away from theextension 730 is overcome and the distance between the distal ends ofthe first and second shafts 716, 718 decreases. As the adjuster 720 ismoved towards the proximal extreme of the guide 748, the spring pushesthe guide 748 away from the extension 730 and the distance between thedistal ends of the first and second shafts 716, 718 increases.

The second handle 714 has a second shaft 718 extending therethrough. Thesecond shaft 718 may have the same configurations and be made of thesame materials as described above with regard to the first shaft 716.Preferably, the second shaft of the second handle has the sameconfiguration as the first shaft of the first handle with which it is tobe used, as illustrated in FIGS. 38-48.

Preferably, as shown in FIG. 49, the upper edges 738 and 740 of thedistal ends of the first and second shafts 736, 715 are slightlyindented relative to the lower edges 742 and 744 to reduce thepossibility of the urethra being pinched during the sling implantationprocedure.

A further aspect of the present invention is a blunt dissector fordissecting the body tissue without scoring or creasing the tissue orbone with which it comes in contact. The blunt dissector is adapted forinsertion into the first and second shafts of the sling applicationdevice and protrudes from the distal ends of the shafts. The bluntdissector can be used as a component in the sling application system.

The blunt dissector may be an obturator 1110 as shown in FIG. 50. Theobturator comprises an elongate, flat shaft 1112 interposed between aflexible section 1114 located at the distal end of the shaft and ahandle 1116 located at the proximal end of the shaft 1112. When theobturator 1110 is inserted into the first and second shafts 716 and 718of the sling application device, the flexible section 1114 bends topermit the obturator 1110 to conform to the curves near the distal endsof the shafts 716 and 718. The flexible section 1114 has a generallyrigid tip 1118 at its distal end which extends from the distal ends ofthe first and second shafts 716 and 718 when the obturator 1110 isinserted therein. The generally rigid tip 1118 prevents scoring of thetissue or bone with which it comes in contact when the first and secondshafts 716, 718 are advanced through tissue. In an alternate embodiment,the flexible section may have an opening near its distal end to increaseflexibility.

The shaft 1112 of the obturator may be made of a variety of materialssuch as polycarbonate, nylon, polypropylene, and Acrylonitrile ButadieneStyrene (ABS). A preferred material is ABS.

The flexible section 1114 of the obturator may be made of any of anumber of materials, including polycarbonate, nylon, polypropylene, andABS. Preferably, the flexible section 1114 is made of ABS.

The generally rigid tip 1118 of the obturator may be made of materialssuch as polycarbonate, nylon, polypropylene, and ABS. Preferably, thegenerally rigid tip 1118 is made of ABS.

When the obturator 1110 is inserted into the first and second shafts716, 718, the generally rigid tip of the obturator 1118 protrudes fromthe distal ends of the shafts 716, 718. Preferably, the generally rigidtip 1118 protrudes a distance of from about 0.1 inch to about 0.25 inchfrom the lower edges 742, 744 of the distal end of the shafts 716, 718.More preferably, the generally rigid tip 1118 protrudes a distance ofabout 0.20 inch from the lower edges 742, 744 of the distal end of theshafts 716, 718.

Yet another aspect of the present invention is a sling introducer 1210adapted for releasably engaging a sling 1211 and introducing the sling1211 into the body tissue without the use of sutures. The slingintroducer 1210 can be used as a component in the sling applicationsystem and is adapted for insertion into and advancement through thefirst and second shafts 716, 718 of the sling application device 710.Alternatively, the sling introducer can be used in conjunction withlaparoscopic trocars.

A representative sling introducer 1210 is shown in FIGS. 51 and 52. Thesling introducer 1210 can be made of any of a number of materials suchas polyethylene, PET or vinyl. Preferably, the sling introducer 1210 ismade of generally rigid vinyl.

The sling introducer 1210 of FIG. 51 has a narrow elongate distal tip1212 and a pouch 1214 at the proximal end. The elongate distal tip 1212of the sling introducer of the sling introducer is configured to passthrough the first and second shafts 716, 178 of the sling applicationdevice. The sling introducer 1210 is sufficiently long to permit thedistal tip 1216 of the sling introducer to protrude from the proximalend of the opening 725 in the first handle of the sling applicationdevice 710 while the sling 1211 protrudes from the proximal end of theopening 727 in the second handle of the sling application device 710.

The pouch 1214 of the sling introducer is sized to receive a sling 1211therein. The slings 1211 introduced with the sling introducer 1210 canbe long enough to extend between two suprapubic incisions or may beshorter slings designed to be attached to the pubic bone with sutures.Long and short slings suitable for use with the present invention aredisclosed in U.S. patent application Ser. No. 09/023,398, entitled“Stabilization Sling for Use in Minimally Invasive Pelvic Surgery”(VESITEC.023A), filed Feb. 13, 1998, now issued U.S. Pat. No. 6,042,534,issued Mar. 28, 2000, and the identically titled U.S. Provisional PatentApplication Ser. No. 60/038,379, filed Feb. 13, 1997, the disclosures ofwhich are incorporated herein by reference.

The pouch 1214 is relatively flexible, and is preferably made of a soft,pliable plastic such as polyethylene, PET or vinyl. In some embodiments,the pouch 1214 may be reinforced by a stiffener to provide some rigidityalong the edges as discussed above. The proximal end of the pouch 1214may be sufficiently wide to maintain the sling 1211 in a flatorientation. Alternatively, the pouch of the sling introducer 1210 maybe rolled up such that the sling is also in a rolled configuration.During introduction of the sling into the opening or pocket in the bodytissue, the sling 1211 may be converted to a flat configuration.

In one embodiment, the pouch 1214 has pores 1218 therein as shown inFIG. 51 to facilitate re-hydration or soaking treatments of the slingmaterials. In particular, the porous pouch 1214 permits solutions inwhich the pouch is placed to contact the sling inside the pouch. Suchsolutions include saline solutions and antibiotic solutions. In thisway, the pores facilitate treatments in which the sling is soaked inantibiotics to prevent the growth of microorganisms on the surface ofthe sling after the sling 1211 is introduced into the body. The poresalso permit gas sterilization of the sling while it is inside the pouch.

In this embodiment, the pouch 1214 may be made of a variety ofmaterials, such as PE, PET, or vinyl. Preferably, the pouch is made ofclear material to permit visualization of the sling when it is insidethe pouch. Preferably, the pouch has pore sizes from about 0.10 inch toabout 0.25 inch. Preferably, the pouch 1214 is made of vinyl having apore size of about 0.125 inch.

In alternate embodiments, the pouch 1214 may be nonporous. Such pouchesmay be made of the same materials as described above for the porouspouches. However, the nonporous pouches do not have pores formedtherein.

Yet another aspect of the present invention is a tissue cutter 1310,1312 for cutting tissue disposed between the distal ends of the firstshaft and the second shaft. As shown in FIG. 53, the tissue cutter 1310comprises a razor 1312 housed in a razor assembly 1314. A flexiblecatheter 1316 extends from the distal portion of the razor assembly1314. A lumen 1318 extends through the catheter 1316. The width ofcatheter 1316 of the tissue cutter is slightly smaller than the width ofthe second shaft 718 of the sling application device 710, such that thecatheter 1316 can be inserted inside the second shaft 718. The tissuecutter 1310 can be used as a component of the sling application system.

In the tissue cutter shown in FIG. 53, the razor assembly 1314 comprisesa handle 1320 having a thumb button 1322 at its proximal end and anelongate catheter 1316 adapted to receive the razor 1312 therein. Thethumb button 1322 is movable between a proximal position and a distalposition and is biased towards the proximal position by a spring 1324inside the handle. When the thumb button 1322 is depressed, theresistance of the spring 1324 is overcome, and the thumb button 1322engages the razor 1312, moving the razor 1312 to a position in which itprotrudes from the distal end of the catheter 1316. When the thumbbutton 1322 is released, the razor retracts inside the catheter.

The razor 1312 is slightly smaller in width than the lumen of thecatheter 1316. The width of the razor 1312 is generally the same as thedesired width of the sling 1211 which will be inserted according to theprocedure described below. In addition, as shown in FIG. 53, the razor1312 is slightly tapered at its distal end.

Although several embodiments of the sling application device and thecomponents of the sling application system have been described above,those skilled in the art will appreciate that other configurations arecompatible with the operation of the device and the system. For example,a spring biased trigger on the first handle of the sling applicationdevice may substitute for the articulating lock for adjusting thedistance between the distal ends of the first and second shafts. Suchadditional configurations are also contemplated by the presentinvention.

The sling application device is used as follows. The method is performedwith the patient in the dorsal lithotomy position. In some methods apocket or opening 11 is created in the tissue between the urethra andthe upper vaginal wall using any of the methods and devices disclosedherein. In such methods, the first and second shafts 716 and 718maintain the opening or pocket in a configuration in which the sling canbe introduced.

Alternatively, the sling application device can be used to create theopening or pocket 11 in the tissue between the urethra and the uppervaginal wall.

Both the methods in which the sling application device maintains theopening or pocket and the methods in which the sling application devicecreates the opening or pocket are described below.

Each of the above described embodiments of the sling application devicecan be used according to the method described below and shown in FIGS.54-65.

After inserting an obturator 1110 into the lumen 711 of the first shaftsuch that the generally rigid tip 1118 extends from the distal end ofthe first shaft, the first shaft 716 is inserted percutaneously. Forexample, the first shaft 716 may be inserted into a first suprapubicincision 60, which is preferably approximately 1 to 1.5 inches inlength, and is located above a pubic tubercle. The first shaft 716 isadvanced into the patient's body and guided along the back side of thepubic bone to the upper vaginal wall. Once the vaginal wall is tented,placement is visually realized and lateral placement can then beadjusted. As shown in FIG. 54, the sling application device is thenrotated 90° such that the distal end of the first shaft 716 is directedperpendicular to the urethra 64 facing the tissue 62 between the urethra64 and the upper vaginal wall 66, creating and/or maintaining an openingor pocket in the tissue between the urethra and the upper vaginal wall.With the embodiments shown in FIGS. 47 and 48, the sling applicationdevice will rotate 90° as the device passes along the back of the pubicbone.

After inserting an obturator 1110 into the lumen 713 of the second shaftsuch that the generally rigid tip 1118 extends from the distal end ofthe second shaft 718, the second shaft 718 is inserted percutaneously.For example, the second shaft may be inserted into a second suprapubicincision 60, which is preferably approximately 1 to 1.5 inches inlength, and is located above a pubic tubercle. The second shaft 718 isadvanced into position as described above such that the distal end ofthe second shaft 718 is perpendicular to the urethra 64 facing thetissue 62 between the urethra 64 and the upper vaginal wall 66, therebycreating and/or maintaining an opening in the tissue between the urethraand the upper vaginal wall. As shown in FIG. 55, at the completion ofthis step, the distal ends of the first and second shafts 716, 718oppose each other in the tissue 62 between the urethra 64 and the uppervaginal wall 1566.

After the sling application device is in position, the obturators 1110are removed from the first and second shafts 716, 718 and the first 712and second 714 handles are locked together with the adjuster 720 at itsmost proximal point, as shown in FIG. 56. The adjuster 720 is advancedtowards the distal extreme of the guide 748, progressively decreasingthe distance between the distal ends of the first and second shafts 716,718 as shown in FIGS. 57 and 58. During this process, the physician mayobserve the inner wall surface of the urethra 64 with a cystoscope toavoid pinching the urethra. The physician also observes the uppervaginal wall 66 to avoid pinching. When the first and second shafts 716,718 have been properly positioned, no pinching is observed at either theinner wall of the urethra or the upper vaginal wall. Correct placementis confirmed through touch and by visualizing a bulge in the uppervaginal wall at the desired positions.

Once correct placement has been obtained, the adjuster 720 is advancedto the distal extreme of the guide 748, compressing the tissue 62between the distal ends of the first and second shafts 716, 718, asshown in FIG. 58.

In the methods in which the sling application device 710 creates thepocket or opening in the tissue between the urethra and the uppervaginal wall, the tissue cutter 1310 is then inserted into the secondshaft 718 as shown in FIG. 59. When the thumb button 1322 of the razorassembly 1314 is depressed, the razor 1312 extends out of the distal endof the second shaft 718 and cuts the tissue 62 disposed between thedistal ends of the first and second shafts 716, 718, creating acontinuous opening 11 or pocket sized to receive the sling. The thumbbutton 1322 of the razor assembly 1314 is then released, causing therazor 1312 to retract within the second shaft 718. The razor assembly1314 is then removed from the second shaft 718.

In both the methods in which the sling application device maintains thepocket or opening and the methods in which the sling application devicecreates the pocket or opening, a sling or a sling introducer 1210 havinga releasably engaged sling 1211 attached thereto is inserted through theopening 727 of the second handle and into the lumen of the second shaft718, as shown in FIG. 60. The proximal end of the sling 1211 extendsbeyond the proximal end of the sling introducer 1210. Long and shortslings suitable for use with the present invention are disclosed in U.S.patent application Ser. No. 09/023,398, entitled “Stabilization Slingfor Use in Minimally Invasive Pelvic Surgery” (VESITEC.023A), filed Feb.13, 1998, now issued U.S. Pat. No. 6,042,534, issued Mar. 28, 2000, andthe identically titled U.S. Provisional Patent Application Ser. No.60/038,379, filed Feb. 13, 1997, the disclosures of which areincorporated herein by reference.

Preferably, a porous sling introducer 1210 is used and the porous slingintroducer 1210 with the sling 1211 attached thereto is soaked in awetting and/or antibiotic solution as described above prior to insertioninto the first shaft.

The elongate distal end 1212 of the sling introducer is advanced throughthe 2opening 727 in the second handle, into the lumen of the secondshaft 718, into the lumen of first shaft 716, and out the opening 725 inthe first handle as shown in FIG. 61. While holding the proximal end ofthe sling 1211, the elongate distal end 1212 of the sling introducer1210 is pulled. The sling introducer 1210 is advanced until it exits theopening in the first handle 725, leaving the sling 1211 within the firstand second shafts 716, 718, as shown in FIG. 62. Following this step,the sling 1211 is located within the first 716 and second 718 shafts andextends out of the proximal ends of the openings 725,727 in the firstand second handles. As shown in FIG. 63, the end of the sling 1211extending out of the proximal end of the opening in the first handle isgrasped and the second shaft 718 is removed from the patient's body,leaving the sling 1212 in the opening 11 in the tissue which wasformerly occupied by the second shaft.

As shown in FIG. 64, the proximal end of the sling 1212 which hadformerly been inside the second shaft 718 is grasped, and the firstshaft 716 is removed from the patient's body. After this procedure, thesling 1211 passes through the continuous opening in the patient's bodytissue created by the above procedure, as shown in FIG. 65.

The sling 1212 may then be secured to a structure, such as the pubicbone by anchoring, stapling, riveting, or sewing to suspend or stabilizethe bladder neck or create a platform to stabilize the urethral floorusing approaches such as those disclosed in U.S. patent application Ser.No. 09/023,398, entitled “Stabilization Sling for Use in MinimallyInvasive Pelvic Surgery” (VESITEC.023A), filed Feb. 13, 1998, now issuedU.S. Pat. No. 6,042,534, issued Mar. 28, 2000, the identically titledU.S. Provisional Patent Application Ser. No. 60/038,379, filed Feb. 13,1997, and U.S. Pat. No. 5,611,515, issued Mar. 18, 1997 to Benderev etal., the disclosures of which are incorporated herein by reference.Tension on the sling may be adjusted using procedures such as thosedisclosed in the U.S. Pat. No. 5,611,515, issued Mar. 18, 1997 toBenderev et al., the disclosure of which is incorporated herein byreference, to support the bladder neck or stabilize the urethral floor,thereby maintaining or improving urinary continence.

Detachable Member Sling Application Device and Retrieval Device

Another aspect of the present invention relates to a detachable membersling application device resembling the guide member placement devicediscussed above.

In general, the detachable member sling application device comprises ahousing with an introduction shaft having a lumen extending therethroughconnected to the housing. A detachable member is located on the distalend of the introduction shaft, the detachable member being connected toat least one of the sutures attached to the sling. The lumen in theshaft of the detachable member sling application device is capable ofreceiving a sling therein. Preferably, the sling is in an accordion likeconfiguration when inside the lumen. The accordion like configurationmay consist of random folds.

Optionally, the detachable member sling application device may furthercomprise an axially movable needle located inside the lumen of theintroduction shaft. The needle, which comprises a needle shaft and asharpened point, is extendable from the introduction shaft.

As illustrated in FIGS. 66-81, the shaft bends toward its distal end inthe same manner as discussed above with regard to the guide memberplacement device.

A detachable member sling application device 1410—according to thepresent invention is depicted in FIGS. 66-79. The detachable membersling application device comprises a housing 1412 and a shaft 1414 witha lumen 1416 extending therethrough. The shaft 1414 has an engagingmember 1411 near its distal tip for engaging a detachable member.Preferably, the engaging member 1411 comprises an annular ring on theouter surface of the shaft.

An axially movable inner shaft 1440 is located inside the shaft 1414 andis extendable therefrom and retractable therein. The axially movableinner shaft 1440 has a lumen extending therethrough. Movement of theaxially movable inner shaft 1440 is controlled by an actuator 1442 whichpivotally engages the housing 1412. Pivoting the actuator 1442 distallycauses the axially movable inner shaft to move distally.

An axially movable plunger 1444 is located inside the axially movableinner shaft 1440 and is extendable therefrom and retractable therein.Movement of the axially movable plunger 1444 is controlled by a button1446 which slidably engages the housing 1412. The button 1446 is movablebetween a first proximal position, a second intermediate position, and athird distal position. When the button 1446 is in first proximalposition, sharpened point 1425 of the axially movable needle 1422 isretracted in the detachable member.

An axially movable needle 1422 having a shaft 1423 and a sharpened point1425 at its distal end passes through an aperture in a deployment member1448 which is located inside a detachable member 1424 located at thedistal end of the shaft 1414. A spring 1413 is disposed between thedeployment member 1448 and the detachable member 1424. The engagingmember 1411 on the distal end of the shaft 1414 releasably engages thedetachable member 1424. Preferably, the detachable member comprises acup.

The detachable member 1424 has an engaging surface 1426 which engagesthe distal end of the shaft and a connecting member 1450. The connectingmember 1450 is connected to at least one suture 1428 attached to a sling1418 located in the lumen of the shaft 1414. Preferably, the sling 1418is in an accordion like configuration inside the shaft 1414 to reducethe amount of space it occupies.

When the button 1446 is in the intermediate position,-the sharpenedpoint 1425 of the axially movable needle 1422 is extended from thedetachable member 1424 so as to permit the tissue to be easily puncturedwhile the device is advanced. When the button 1446 is in the distalposition, the axially movable needle 1422 is maximally extended from thedetachable member 1424 such that the shaft 1423 protrudes from thedetachable member 1424 to permit extension through the hiatal area intothe vagina for ease of grasping and securing.

Another aspect of the present invention is a retrieval device forintroducing a sling into an opening or pocket in a body tissue. Oneembodiment of the retrieval device is illustrated in FIG. 67. Theretrieval device 2010 comprises a handle 2012 attached to a shaft 2014having an engaging member 2016 near its distal end.

The handle 2012 of the retrieval device may have a variety ofconfigurations which may vary depending on anatomical considerations andthe type of procedure being performed. For example, the handle may havea similar configuration as that of the detachable member slingapplication device shown in FIG. 66.

Similarly, the shaft 2014 of the retrieval device may have the sameconfiguration as the shaft 1414 of the detachable member slingapplication device 1410 shown in FIG. 66. Preferably, the engagingmember 2016 comprises an annular ring on the outer surface of the shaft2014.

In one embodiment, the retrieval device 2010 may be a modifieddetachable member sling application device 1410 having a hollow or solidshaft and lacking the actuator 1442, the button 1446, the detachablemember 1424, the sling 1418, and the mechanism inside the shaft fordeploying the detachable member.

The distal end of 2018 the shaft 2014 of the retrieval device has anengaging member 2016 adapted to engage the detachable member 1424.Preferably, the engaging member 2016 comprises an annular ring on theouter surface of the shaft. The shaft 2014 of the retrieval device maybe solid or may have a hollow interior.

Although the detachable member sling application device 1410 and theretrieval device 2010 described above and depicted in FIGS. 66 and 67may be used in a variety of procedures, a representative procedure forusing the device to apply a sling beneath the female urethra isdescribed below and depicted in FIGS. 68-81.

The first step of the procedure involves creating an opening or pocket11 in the tissue 62 between the urethra 64 and the upper vaginal wall 66into which the sling 1418 can be introduced. The opening or pocket 11may be created in a variety of ways, including those described hereinand in U.S. patent application Ser. No. 09/023,398, entitled“Stabilization Sling for Use in Minimally Invasive Pelvic Surgery”(VESITEC.023A) filed Feb. 13, 1998, now issued U.S. Pat. No. 6,042,534,issued Mar. 28, 2000, and the identically titled U.S. Provisional PatentApplication Ser. No. 60/038,379, filed Feb. 13, 1997, the disclosures ofwhich are incorporated herein by reference.

A preferred method of creating the pocket involves hydrodissection. Asshown in FIG. 68, a syringe 1430 filled with saline is inserted throughthe vaginal wall 66 into the tissue 62 between the urethra and the uppervaginal wall. A bolus of saline is dispensed into the tissue, creatingan opening or pocket 11 therein as shown in FIG. 68. Preferably, thebolus comprises about 4 cc of saline. The shaft 1414 of the detachablemember sling application device is inserted percutaneously. For example,the shaft 1414 may be inserted percutaneously through a first suprapubicincision 61. The shaft 1414 of the detachable member sling applicationdevice 1410 is inserted therein. The shaft 1414 of the detachable membersling application device 1410 is advanced through the patient's bodytissue along the back side of the pubic bone to the opening or pocket 11created in the tissue 62 between the urethra 64 and the upper vaginalwall 66, as shown in FIG. 69. During advancement of the shaft 1414, thebutton 1446 may be advanced from the most proximal position, in whichthe sharpened point 1425 of the needle is within the detachable member1424, to the intermediate position, in which the sharpened point 1425 ofthe needle extends from the detachable member. In particular, thesharpened point 1425 may be extended to dissect through muscle groups.

The distal end of the shaft 1414 is advanced percutaneously orlaparoscopically to the bottom of the pocket or opening 11 and thebutton 1446 is advanced to the most distal position, in which the needle1422 is maximally extended and the sharpened point 1425 passes throughthe upper vaginal wall 66 as shown in FIG. 70. The needle 1422 issecured on the vaginal side with a device such as a hemostat 1432 asshown in FIG. 71.

As shown in FIG. 72, the detachable member 1424 is then detached fromthe distal end of the shaft 1414 by pivoting the actuator 1442 distally,thereby causing the inner shaft 1440 to move distally such that itcontacts the deployment member 1448 and pushes the detachable member1424 off the distal end of the shaft 1414.

As illustrated in FIG. 73, the needle 1422 is toggled within the pocketor opening 11 such that the engaging surface 1426 of the detachablemember will be accessible to the engaging member 2016 of a retrievaldevice 2010. Preferably, the needle is toggled from about 30° to about150°. More preferably the needle is toggled from about 60° to about120°. In a highly preferred embodiment, the needle is toggled about 90°.

As will be appreciated by those skilled in the art, other methods ofpositioning the detachable member for engaging the engaging member of aretrieval device may be used with embodiments of the detachable membersling application device which do not have the axially movable needle.

The shaft 2014 of a retrieval device is advanced percutaneously orlaparoscopically into the opening or pocket 11 as shown in FIG. 74. Forexample, the shaft may be advanced into the opening or pocket through asecond suprapubic incision 60.

The distal end of the shaft 2014 of the retrieval device is insertedinto the detachable member 1424 and the engaging member 2016 engages theengaging surface 1426 of the detachable member 1424 as shown in FIG. 75.As shown in FIG. 76, the needle 1422 protruding through the vaginal wall66 is then pulled out of the deployment member 1448 and removed from thevagina so as not to draw bacteria back into the pelvic area.

As the shaft 2014 of the retrieval device is withdrawn from the pocketor opening 11, the connecting member 1450 on the detachable member 1424pulls the sutures 1428 connected to the sling 1418 out of the shaft 1414of the detachable member sling application device 1410, as illustratedin FIG. 77. As the shaft 2014 of the retrieval device is withdrawnfurther from the pocket or opening 11, the sling 1418 and the sutures1428 connected thereto are pulled out of the shaft 1414 of thedetachable member sling application device 1410, as illustrated in FIG.78.

The shaft 1414 of the detachable member sling application device 1410and the shaft 2014 of the retrieval device 2010 are withdrawn from thepatient's body as shown in FIG. 79. The sling 1418 is thereby left inthe opening or pocket 11 between the urethra 64 and the upper vaginalwall 66 such that the sutures 1428 extend from the first and secondsuprapubic incisions 60, 61 patient's body, as shown in FIG. 80.

Preferably, the sutures 1428 or integral attachment members attached tothe sling 1418 have markings 1436 thereon for ensuring that the sling1418 is properly centered beneath the urethra in the opening or pocket11. The markings 1436 on the sutures or integral attachment members areequidistant from the center 1438 of the sling. Following placement ofthe sling 1418 in the opening or pocket 11, the physician crosses thesutures 1428 as shown in FIG. 81. When the markings 1436 on the sutures1428 or integral attachment members are positioned along a lineextending transversely to the patient's abdomen, as shown in FIG. 81,the sling 1418 is properly centered in the pocket or opening 11.

The sling can then be attached to a bone anchor or other structures, andtensioned to support the bladder neck or stabilize the urethral floor,thereby maintaining or improving urinary continence, using approachessuch as those described in U.S. patent application Ser. No. 09/023,398,entitled “Stabilization Sling for Use in Minimally Invasive PelvicSurgery” (VESITEC.023A), filed Feb. 13, 1998, now issued U.S. Pat. No.6,042,534, issued Mar. 28, 2000, the identically titled U.S. ProvisionalPatent Application Ser. No. 60/038,379, filed Feb. 13, 1997 and U.S.Pat. No. 5,611,515, issued Mar. 18, 1997 to Benderev et al., thedisclosures of which are incorporated herein by reference.

Tissue Expander Grasping Device, and Balloon Catheters

A further aspect of the invention relates to hiatal techniques forcreating an opening or pocket in the tissue between the urethra and theupper vaginal wall and devices for use in the hiatal techniques. Thehiatal methods can be practiced without the necessity for a vaginalincision, thus minimizing the risk of infection from the procedure.

As will be described in greater detail below, in the hiatal approach alumen is created in the hiatal tissue between the urethra and the uppervaginal wall. The lumen is then expanded to create an opening or pocketof a size sufficient to accept a sling. The opening or pocket is thenheld open with the tissue expander while a first suture or flexibleguide member is percutaneously advanced into the opening or pocket. Theguide member may be a suture, guide wire, or other structure suitablefor guiding a sling to a desired location. The first suture or flexibleguide member is grasped with a grasping device and withdrawn through thelumen and out of the body. The process is repeated with a second sutureor flexible guide member on the opposite side of the urethra. The twosutures or flexible guide members are then tied together to create aguide for delivering a sling into the pocket. The knotted section of thesuture or guide member is then translocated outside of the body so thatthe progress of the sling along the suture or guide member is unimpeded.

Alternatively, the sling may be attached to the sutures extendingoutside of the body, rolled or restuffed, and drawn into the bodythrough the lumen by pulling on the sutures.

As discussed above, after creation of the lumen in the hiatal tissue,the lumen is expanded to create a pocket or opening. One aspect of thepresent invention relates to balloon catheters for expanding the lumenand creating the pocket or opening. The balloon catheters generallycomprise an outer tube having a lumen extending therethrough and atleast one expandable balloon inside the outer tube. The expandableballoon has a blunt dissection tip at its distal end having sufficientrigidity to allow it to create an opening in a body tissue whencontacting the tissue.

One embodiment of a balloon catheter 536 suitable for use in the hiatalapproach was described above and is shown in FIG. 26.

In the embodiment shown in FIG. 26, there is a single expandable balloon540. In an alternative embodiment of the balloon catheter, there is morethan one balloon. This embodiment permits the creation of an opening orpocket wide enough to accommodate the sling using balloons having asmaller diameter than would a single balloon capable of creating apocket of that width. In this way, tearing of tissue above and below thepocket is minimized.

FIG. 82 shows a preferred embodiment 1536 in which there are twoexpandable balloons 1540 and 1541 in the lumen of the outer tube 1538which are joined at their distal ends. Preferably, the expandableballoons are joined at their distal ends by a blunt dissection tip 1546.The blunt dissector tip may comprise a plastic or metal cap.Alternatively, the ends of the two balloons may be potted together. Inthe embodiment of FIG. 82, the two balloons have a common inflationtube. However, those skilled in the art will appreciate that theballoons may also have separate inflation tubes.

FIG. 83 shows the embodiment of FIG. 82 in which the balloons 1540, 1541have been inflated. As illustrated in FIG. 83, the balloons 1540, 1541have a generally cylindrical configuration when inflated. In thisembodiment, each balloon 1540, 1541 may be from about 2 cm to about 3 cmin length and has a diameter when expanded of from about 1 cm to about2.5 cm. In a preferred embodiment, each balloon 1540, 1541 is from about2 cm to about 3 cm in length and has a diameter when expanded of fromabout 1.5 cm to about 2 cm. More preferably, each balloon is about 2.75cm in length and 2.5 em in diameter when expanded.

Some physicians prefer procedures which take place beneath the pelvicfloor so as to avoid any unnecessary disruption of muscle, the slingsare preferably about 1.5 cm to about 6 cm in length and about 2 cm inwidth. More preferably, the slings used in such procedures are 2.5 cm to4 cm in length, although longer slings may be more manageable forgeneral surgeons since they allow for slippage off center during 30placement.

Other physicians prefer procedures which break through the pelvic floorand produce scarring which may reinforce the area. In such procedures,the slings may be as long as 20-25 cm. These long slings minimize thelength of attaching suture and permit more tissue ingrowth whileproviding security against suture breakage. Preferably, the slings usedin such procedures are about 2 cm wide.

Those skilled in the art will appreciate that the sling dimensions canbe varied as appropriate. In any case, however, it is preferred that theballoon on the balloon catheter is appropriately sized to create apocket or opening capable of accommodating the sling.

Alternatively, a balloon catheter 1636 having a flat profile balloon1640 may be used to create the lumen. The flat profile balloon 1640 iscapable of forming a flat pocket sized to receive a sling while avoidingthe unnecessary dilation or tearing of tissue above and below the slingpocket which may occur if a cylindrical balloon was used to create thepocket. Preferably, the flat profile balloon 1640 has a square orrectangular shape when inflated. However, those skilled in the art willappreciate that other shapes are compatible with the present inventionand that the shape may be readily modified to be compatible with theparticular device or procedure used.

The flat profile balloons 1640 are preferably made of two sheets ofnoncompliant material such as mylar, polyethylene, or PET.Alternatively, the balloons may be made by blow molding.

A flat profile balloon 1640 according to the present invention is shownin FIG. 84. As illustrated, the balloon 1640 has a series of internalnon-expansive ribs 1650 which serve to maintain a shallow profile afterexpansion, direct the flow of air to promote even unrolling duringexpansion, reduce buckling in critical areas after expansion, andprovide a conduit structure which delivers a consistent expansion oftissue into the desired shape. The internal structure of the catheterand balloon 1640 are further illustrated in the cross sectional views ofFIGS. 85 and 86.

As illustrated in FIG. 84, the balloon 1640 is located at the distal endof a generally rigid inflation tube 1642 which extends through theinterior of the balloon 1640. The inflation tube 1642 provides agenerally rigid support structure during advancement and placement ofthe balloon 1640 in the body tissue. Preferably, the inflation tube 1642has a series of fill holes 1658 in the interior of the balloon 1640which promote uniform inflation of the balloon. However, those skilledin the art will appreciate that a single fill hole may also be used.

In one embodiment, shown in FIG. 85, the inflation tube 1642 has twolumens in its interior. One lumen, the guide lumen 1652, is adapted toreceive a guide member, while the other lumen, the inflation lumen 1654,is for inflation of the balloon and is in fluid communication with theinterior of the balloon. In an alternative embodiment, the catheter hasa single inflation lumen.

Those skilled in the art will appreciate that the catheter may beprovided with more than two lumens to accommodate other instrumentsnecessary to perform the surgical procedure.

The inflation tube has a luer tip 1656 at its proximal end which isadapted to engage a syringe filled with saline or sterile water. Whenthe plunger of the syringe is depressed, fluid is force through theinflation lumen 1642 and out of the fill holes into the interior of theballoon, causing the balloon 1640 to inflate. When the plunger of thesyringe is retracted, a vacuum is created, drawing the fluid out of theballoon 1640 and causing the balloon to deflate 1640.

In a preferred embodiment, the balloon 1640 is rolled on the exteriorsurface of the inflation tube 1642 to reduce its entry profile.

Those skilled in the art will appreciate that the above describedballoon catheters 536, 1536, 1636 can be used to dilate body tissues incontexts other than the hiatal procedures discussed below. For example,the balloon catheters 536, 1536, 1636 may be utilized in the tissuedissector/dilator 510 described above, or may be used to create apre-formed opening for receiving the guide member placement devices 10,1910, the sling application devices 710, 810, 910, 1010, or thedetachable member sling application devices 1410 described above.

Additionally, the balloon catheters 536, 1536, 1636 of the presentinvention can also be used to create the opening or pocket in the tissuebetween the urethra and the upper vaginal wall in transvaginalincontinence treatments. In such transvaginal procedures the ballooncatheter is inserted through the upper vaginal wall into the area inwhich the opening or pocket is to be made. The balloon is then expanded,creating the opening or pocket for receiving a sling. In some instances,the physician may use the balloon catheters in conjunction withtransvaginal bone anchor implantation devices such as those disclosed inU.S. patent application Ser. No. 08/744,439, entitled “TransvaginalAnchor Implantation Device,” filed Nov. 8, 1996, now issued U.S. Pat.No. 6,053,935, issued Apr. 25, 2000, the disclosure of which isincorporated herein by reference. However, use of the balloon cathetersin conjunction with transvaginal bone anchor implantation devices mayimpact the expense of such procedures.

The balloon catheters described above and depicted in FIGS. 2B and 82-86may be introduced into the body in a number of ways. In one method aneedle or guide member is inserted into the hiatal tissue to the desiredlocation. The needle or guide member is inserted into the guide lumen ofthe catheter. The catheter is advanced along the guide member or needleto the desired location. A syringe filled with saline or sterile wateris attached to the luer tip at the end of the catheter and the plungerof the syringe is depressed, ejecting the fluid from the syringe andcausing the balloon to inflate. The inflated balloon dilates or tearsthe tissue thereby creating a shallow opening or pocket adapted toreceive a sling.

In an alternate procedure, a hollow needle or trocar is introduced intothe body tissue and advanced to the desired location. A ballooncatheter, which may have a single inflation lumen, is passed through thelumen of the needle or trocar and advanced to the end. The needle ortrocar is partially withdrawn from the patient's body to expose theballoon. The balloon is inflated and deflated as described above tocreate an opening or pocket adapted to receive a sling.

Further aspects of the present invention relate to tissue expanders 1710for expanding an opening or pocket in a body tissue and grasping devices1810 for grasping a suture advanced into the opening or pocket.

In general, the tissue expander comprises a. tube with a lumen extendingtherethrough, an expandable and collapsible member attached to the tubefor insertion into the opening within the body tissue and expansionthereof, and an expansion and collapse control in communication with theexpandable and collapsible member for moving the expandable andcollapsible member between a first position in which it is collapsed anda second position in which it is expanded.

One embodiment of a tissue expander 1710 according to the presentinvention is shown in FIG. 87. The tissue expander comprises a tube 1712with a lumen 1714 extending therethrough. Preferably, the lumen 1714 ofthe tube 1712 is of sufficient diameter to permit a visualizer, such asa fiberoptic scope, and a grasping device to be simultaneously housedtherein.

An expansion basket 1716 is attached to the tube 1712. Preferably, theexpansion basket 1716 comprises a plurality of wires 1718 joined attheir distal ends by a tip 1720 which is connected to a pull wire 1722.The expansion basket 1716 is movable between a first position in whichit is collapsed (indicated with solid lines) and a second position inwhich it is expanded (indicated with dashed lines) as shown in FIG. 87.When the pull wire 1722 is pulled towards the proximal end of thedevice, the expansion basket 1716 moves to the expanded position. Whenthe pull wire 1722 is released, the expansion basket 1716 collapses.

The expansion basket 1716 may be fabricated from a variety of materialssuch as stainless steel or Nitinol. Preferably, the expansion basket1716 is made of stainless steel.

The expansion basket 1716 may expand the tissue from about 0.25 inch toabout 1.5 inches. Preferably, the expansion basket 1716. expands thetissue from about 0.5 inch to about 1.25 inches. In a highly preferredembodiment, the expansion basket 1716 expands the tissue about one inch.

In an alternative embodiment of the tissue expander, a self-expandingnet or a self-expanding mesh tube may be used in place of the expansionbasket.

A further aspect of the present invention relates to a grasping devicewhich is adapted to fit inside the lumen of the tube of the tissueexpander described above. When inserted into the lumen of the tube ofthe tissue expander, the grasping device is axially movable andextendable from and retractable in the lumen of the tube. Generally, thegrasping member comprises a catheter with a grasper on its distal end.

A grasping device 1810 according to the present invention is shown inFIG. 88. The grasping device 1810 comprises an elongate member 1812 andself expanding grasping basket 1814 attached to the distal end of theelongate member 1812.

Preferably, the grasping device 1810 is adapted to fit inside the tube1712 of the tissue expander 1710. When the self-expanding graspingbasket 1814 is inside the lumen of the tube 1712 of the tissue expander1710, it is held in a collapsed configuration by the tube 1712. However,when the self-expanding grasping basket 1814 is extended outside thetube 1712, it expands. Preferably, in its expanded state, theself-expanding grasping basket 1814 on the grasping device 1810 fitsinside the expansion basket 1716 of the tissue expander 1710. When thegrasping device 1810 is retracted back into the lumen 1714 of the tube1712 it collapses.

The above grasping devices 1810 and tissue expanders 1710 can be used ina wide variety of surgical procedures in which it is necessary to expandan opening in a body tissue and grasp a suture which has been advancedinto the expanded opening. For illustrative purposes, the use of theabove devices in a hiatal bladder neck stabilization procedure isdescribed below.

FIG. 89 shows the urethra 64, the vagina 1836, the hiatal tissue 62between the urethra and the upper vaginal wall, and a target site 1816for insertion of a device for creating a lumen 1818 in the hiataltissue. In the hiatal bladder neck stabilization procedure disclosedherein, the urethra 64 is straightened prior to creation of the lumen1818 in the hiatal tissue.

As shown in FIG. 90, the urethra 64 can be straightened with a Foleycatheter 1820 inside a large bore tube 1822. The large bore tube 1822fits securely over the Foley catheter and extends out of the urethra.Preferably, the large bore tube is sufficiently firm to rigidify theFoley catheter.

Preferably, the large bore tube 1822 comprises a metal shaft. In apreferred embodiment the metal shaft includes a means to measure thelength of the urethra from the bladder neck to the proximal end. In someembodiments, the large bore tube 1822 has guide means thereon whichallow the needle 1830 or other dissecting device for dissecting thehiatal tissue, such as a cutter knife, to be guided to the desired site.Such devices are described in U.S. patent application Ser. No.09/023,533, entitled “Method and Apparatus for Minimally Invasive PelvicSurgery,” (VESITEC.028A) filed Feb. 13, 1998, now issued U.S. Pat. No.6,099,547, issued Aug. 4, 2000, and the identically titled U.S.Provisional Patent Application Ser. No. 60/038,380, filed Feb. 13, 1997,the disclosures of which are incorporated herein by reference.

As shown in FIG. 90, the Foley catheter 1820 is inserted into theurethra 64 and advanced to the bladder neck 1826. When the balloon 1828of the Foley catheter is inside the bladder neck 1826, it is inflated.Alternatively, the urethra 64 may be straightened with a urethroscope orby other methods familiar to those skilled in the art.

As shown in FIG. 91, a large bore needle 1830 is inserted into thehiatal tissue 62 between the urethra 64 and the upper vaginal wall 66 atthe target site 1816 indicated in FIG. 89. An appropriately sized needlemay be selected by measuring the distance between the balloon 1828 ofthe Foley catheter 1820, which is positioned at the bladder neck 1826,and the external urethra. The needle should be slightly shorter than themeasured length. For example, the needle may be approximately 0.25 inchless than the measured length.

The needle 1830 may be guided by eye or may be mechanically guided topenetrate the hiatal tissue parallel to the without penetrating theupper vaginal wall. The needle is advanced parallel to the urethra 64below the midline of the urethra.

As shown in FIG. 92, the needle 1830 is partially retracted and thelumen 1818 in the hiatal tissue 62 which was created by the needle 1830provides an access channel for the devices discussed above.

Alternatively, a bi-polar RF cutter may be used to dissect an opening inthe hiatal tissue. The bi-polar cutting device comprises a pair ofwires, one flexible and one rigid, for cutting a slot from the proximalportion of the hiatus to the bladder neck having a width adapted forreceiving a sling therein. Preferably, the bi-polar cutting devices uses80 Watts of power to cut and coagulate the tissue. In this embodiment,the large bore tube 1822 in which the Foley catheter is placed has aseries of thermistors and associated connectors which providetemperature feedback for use in conjunction with a bi-polar RF cutterdevice. Such devices are described in U.S. patent application Ser. No.09/023,533, entitled “Method and Apparatus for Minimally Invasive PelvicSurgery” (VESITEC.028A) filed Feb. 13, 1998, now issued U.S. Pat. No.6,099,547, issued Aug. 4, 2000, and the identically titled U.S.Provisional Patent Application Ser. No. 60/038,380, filed Feb. 13, 1997,the disclosures of which are incorporated herein by reference.

A balloon catheter 536 is inserted into the bore of the needle 1830 andadvanced beyond the tip of the needle 1830 into the lumen 1832 in thehiatus as shown in FIG. 93. Although FIG. 93 shows the balloon catheter536 depicted in FIG. 26 being used, the balloon catheters 1536 and 1636depicted in FIGS. 82-86 may also be used.

As shown in FIG. 94, the balloon 540 is then inflated with saline orsterile water, dilating the hiatal tissue 62 around the lumen 1818created by the large bore needle 1830. The balloon 540 is then deflatedand the balloon catheter 536 is withdrawn from the patient's body.

The tissue expander 1710 is inserted into the large bore of the needle1830 and advanced beyond the tip of the needle into the lumen 1818 inthe hiatal tissue 62, as shown in FIG. 95. The pull wire 1722 is thenpulled towards the proximal end of the tissue expander 1710, causing theexpansion basket 1716 to adopt the expanded configuration and therebyexpanding the lumen 1818 in the hiatal tissue as shown in FIG. 96.

A fiberoptic scope 1832 is inserted into the tube 1712 of the tissueexpander 1710 and is extended into the interior of the expansion basket1716.

A guide member placement device 10 such as that described above is usedto advance a suture 1834 or guide member from a suprapubic incision,along the back side of the pubic bone toward the upper vaginal wall. Thesuture 1834 or guide member is extended into the expansion basket 1716of the tissue expander 1710 as shown in FIG. 97. The fiber optic scope1832 permits the physician to visualize the position of the suture 1834or guide member in order to determine when the suture 1834 or guidemember is within the expansion basket 1716.

A grasping device 1810 is inserted into the lumen 1714 of the tube 1712of the tissue expander 1710. The self-expanding grasping basket 1814 ofthe grasping device is extended from the tube 1712, causing theself-expanding basket 1814 to expand, as shown in FIG. 97. The suture1834 or guide member 68 is positioned inside the self-expanding basket1814 and the self-expanding basket 1814 is pulled back into the lumen1714 of the tube 1712, causing the self-expanding basket 1834 tocollapse and grasp the suture 1834 or guide member, as shown in FIG. 98.As shown in FIG. 99, the self expanding basket 1814 is withdrawn throughthe tube 1712, drawing the suture toward the outside of the patient'sbody. The grasping device 1810 is removed from the tube 1712, pullingthe suture 1834 outside the patient's body.

A second suture is advanced along the back side of the pubic bone towardthe upper vaginal wall with a guide member placement device as describedabove. The second suture is positioned on the opposite side of theurethra from the first suture and is advanced into the expansion basket,grasped with the grasping basket, and drown outside the patient's bodyas described above. Following this procedure, a second suture or guidemember extends from the patient's body.

The large bore needle 1830 and tissue expander 1710 are then removedfrom the patient's body. The ends of the two sutures are knottedtogether and the ends of the knotted suture extending from thesuprapubic incisions are pulled to draw the knotted suture back into thebody. The knot is advanced out of one of the suprapubic incisionsproviding an uninterrupted suture or guide member extending between thesuprapubic incisions around the urethra. The suture provides a guidepath from the suprapubic incisions around the urethra which may be usedto introduce a sling using a sling introduction catheter as describedabove.

In an alternative embodiment, the large bore needle 1830 is left inplace. A sling is secured to the sutures outside the body, rolled orrestuffed, and then drawn through the bore of the needle and into theopening or pocket in the body tissue by pulling on the ends of thesutures extending from the suprapubic incisions.

The tension on the sling may be adjusted as described above. Boneanchors or other means may be used to secure the sutures as discussedabove to support the bladder neck or stabilize the urethral floor,thereby maintaining or improving urinary continence.

Although this invention has been described in terms of certain preferredembodiments, other embodiments which will be apparent to those ofordinary skill in the art in view of the disclosure herein are alsowithin the scope of this invention. Accordingly, the scope of theinvention is intended to be defined only by reference to the appendedclaims. In addition, for clarity, letter references are used in some ofthe claims. These letter references, however, are not meant to imply anyparticular order for performing the method steps.

Part B

The present invention relates to prefabricated slings for use inurethral floor reconstruction. More particularly, the slings are usefulfor improving or maintaining urinary continence such as by suspending,stabilizing and/or slightly compressing the urethra of an incontinentpatient. The slings are particularly useful for treating patientssuffering from incontinence caused by Intrinsic Sphincter Deficiency(ISD) and/or hypermobility. The slings may also be used to treat otherdisorders in which stabilization and/or compression of the urethra wouldbe beneficial.

The present slings are designed to be implanted in a patient sufferingfrom incontinence using the medical procedure described in more detailbelow. During implantation, the sling is preferably positioned beneaththe bladder neck so that the urethra extends across the center of thesling. The sling is biased towards the urethra through tension appliedto the sling by sutures or other attachment means, which are preferablyanchored to the pubic bone. The resulting bias stabilizes and/orslightly compresses the urethra so that continence is maintained.

Although urethral slings have previously been used to treatincontinence, the present slings are prefabricated, eliminating the needfor the surgeon to prepare them for use during the surgical procedure.The present slings are supplied to the physician in shapes anddimensions adapted for urethral stabilization or suspension, eliminatingthe need for the surgeon to cut the sling material during surgery. Inaddition, the present slings are provided with suture receiving sitesalready prepared so that the surgeon need not manufacture them duringsurgery. The slings may also be provided with reinforced suturereceiving sites to reduce the incidence of tearing about the point ofsuture attachment. Because the surgeon need not fabricate the slingduring surgery, the time required for the surgical procedure is reduced.

In some embodiments, the slings are provided with the suturespreattached. Alternatively, the slings may have preformed integralattachment members which, like the sutures, allow the sling to besuspended from structures such as the pubic bone. In either case, theneed for the surgeon to attach sutures to the sling during surgery iseliminated, thereby simplifying the implantation procedure.

The foregoing features of the present invention overcome theabove-discussed deficiencies of slings currently in use. By simplifyingand shortening the surgical procedure, use of the slings of the presentinvention results in decreased surgical morbidity and mortality.

Referring to FIG. 100, there is disclosed a plan view of a preferredembodiment of the sling 10B of the present invention. The sling of FIG.100 has been cut into a generally elongate shape adapted for urethralstabilization, with a central portion 12B extending between a first endportion 14B and a second end portion 16B. Suture receiving sites 18B areprefabricated in the first and second end portions 14B, 16B of the sling10B. The sling preferably also has a visual indicator 20B. These andother features of the present invention will be described in more detailbelow after discussing the materials from which the sling can beconstructed.

The sling may be fabricated from any of a variety of synthetic ornaturally occurring biocompatible materials. Such materials may befilamentous or non-filamentous, elastic or inelastic, and may be porous,microporous, perforated, or impermeable. The properties of the sling maybe selected as appropriate based on the surgical procedure used toimplant the sling and the application for which the sling is used.

Filamentous materials suitable for use in the slings of the presentinvention include cadaveric or animal tissue such as fascia lata, rectusfascia or processed collagen. Synthetic materials such as polyester,polyurethane, or nylon can also be used. The synthetic filamentousmaterial can be woven or non-woven. Filaments made from syntheticmaterials may be braided together to form strands or threads which canbe braided or woven together to form strips of fabric. Preferably, thesynthetic filamentous material is polyester.

Non-filamentous materials suitable for use in the slings of the presentinvention include silicone, polytetrafluoroethylene (PTFE), polyethyleneterephthalate (PET), PTFE, FEP, or thin films such as latex.

As will be apparent to one skilled in the art, the elasticity of thesling material may also be selected based on the type of surgicalprocedure for which the sling is being used. A suitable elastic materialis knitted polyester.

As will be apparent to one skilled in the art, inelastic or minimallyelastic materials may be preferred for certain procedures such as thosein which the sling is used to create an immobile floor. A preferredminimally elastic material is woven polyester.

The porosity of the material may also be selected based on the type ofsurgical procedure for which the sling is being used. For example,pores, micropores, or perforations permit tissue ingrowth, which isadvantageous to stabilize the sling and reduce erosion from constantmotion.

Additionally, the sling material may be impregnated with antibiotics orother agents which can be delivered from the surface of the sling aswell as through the pores, micropores or perforations. Impregnation withantibiotics or other agents may be facilitated by coating the sling withcollagen.

Impermeable materials may also be useful in certain applications of thesling. Representative impermeable materials include nylons andpolyester. A preferred impermeable material is polyester.

A coating may also be applied to the sling. The coating may be used todeliver a number of compounds, such as antibiotics, heparin,immunosuppressant agents or other drugs. In some embodiments, the drugmay be released over time. The coating also blocks the interstices ofthe underlying sling material, thereby decreasing the risk of infectionby sequestering the interstices of the sling from contact withmicroorganisms encountered during implantation of the sling. Preferably,the coating is absorbed after implantation to facilitate tissue ingrowthinto the interstices, pores, micropores and/or perforations of the slingmaterial.

Suitable coatings include polyglycolic acid, polylactic acid, blends ofpolyglycolic acid and polylactic acid, gelatin, polyvinyl alcohol, andpolyvinyl pyrrolidone. A preferred coating is a smooth layer ofcollagen, such as that provided on the Hemashield® woven double velouravailable from Meadox. (Meadox Medical, 112 Beaver Drive, Oakland, N.J.07436 or Boston Scientific Corporation, One Boston Scientific Place,Natick, Mass. 01760.) The smooth collagen coating protects theinterstices of the underlying sling material from bacterial contactduring implantation, thereby decreasing the risk of infection aspreviously discussed. Additionally, the collagen coating facilitates theuptake of antibiotics to reduce the risk of infection as discussedbelow. After placement in the body, the collagen is gradually absorbed,facilitating tissue ingrowth into the underlying filamentous mesh. Thecollagen coating may also enhance tissue compatibility.

The slings of the present invention may also be made of absorbablematerials. Such absorbable slings preferably remain structurally intactfor at least three months while supporting tissue ingrowth. Thereafter,the slings may be fully absorbed. Preferably, the slings are fullyabsorbed over a period of 3-6 months following the three month period inwhich the sling is intact. Preferably, the absorbable sling is made ofpolylactic acid or polylactic acid/polyglycolic acid copolymers.

The slings of the present invention may be fabricated from directionallyoriented biocompatible materials. Such materials include filamentousmaterials in which the orientation of the filaments is directionallyordered, as well as grained or striated materials in which the grains orstriations are directionally ordered. Alternatively, the material may bea polymeric material in which the orientation of the polymeric chainscomprising the material is directionally ordered. The polymeric materialmay or may not be cross-linked.

The filaments, grains, striations, or polymeric chains in such materialsmay be oriented in a single direction or may be multidirectional.Suitable directionally oriented materials include synthetic materialssuch as Trelex® Natural Mesh (Meadox Medical, 112 Beaver Drive, Oakland,N.J. 07436 or Boston Scientific Corporation, One Boston ScientificPlace, Natick, Mass. 01760.), Hemashield®, and woven and knittedpolyester.

Alternatively, the directionally oriented material may be naturalmaterial such as grained or striated tissue. The tissue may be anallograft, xenograft, or autologous tissue. One advantage of autologoustissue is its ability to revascularize and regrow after implantation.

Tissue for use in allografts can be obtained from cadavers. Cadaverictissue can be harvested according to techniques well known to thoseskilled in the art and may be selected to minimize the risk ofrejection. However, non-cadaveric tissue is generally preferred becauseof patient preference and the perceived risk of cross-contamination.Although the cadaveric tissue may be absorbed after implantation, thescar tissue which replaces the cadaveric tissue provides support for thebladder neck.

Representative sources of autologous tissue for use in the presentslings include striated muscle, fascia lata, rectus fascia, dura,pericardium and the vaginal wall. The same tissue sources may also beused for allografts. Typical sources of xenograft tissue includestriated muscle, bovine fascia, dura, pericardium and collagen.

In addition to the synthetic and naturally occurring biocompatiblematerials enumerated above, those skilled in the art will appreciatethat a variety of other materials may be readily employed in the slingsof the present invention.

In addition to the elongate octagonal sling illustrated in FIG. 100, theslings of the present invention may be cut into a number of othershapes. For example, several alternative elongate shapes suitable foruse in the present invention are shown in FIGS. 101A-101C. These includeparallelograms such as rhomboids (FIG. 101A), hexagons (FIG. 101B), andrectangles (FIG. 101C). In addition, the end portion of the sling may becut into a rounded shape, such as that illustrated in FIG. 103B. Theoptimal shape of the sling is related to anatomical considerations aswell as the surgical procedure used to introduce the sling. Forinstance, slings having rounded ends (FIG. 103B) or tapered ends, suchas the hexagon (FIG. 101B), parallelogram (FIG. 101A), and octagon (FIG.100), may facilitate insertion into the pocket formed during thesurgical procedure discussed in more detail below, since the pocket maynot be precisely rectangular.

The optimal dimensions of the sling can be varied considerably to suitparticular design criteria desired for a particular application andstill embody the present invention. For example, optimal slingdimensions are dependent upon anatomical considerations and the surgicalprocedure used to introduce and attach the sling. For instance, theoptimal length of the sling may be influenced by whether the surgeonprefers to attach a long strip of material to the pubic bone orabdominal musculature with a bone anchor or other securing device. Insuch procedures, the sling may be up to 30 cm in length and may be 1-5cm in width. Preferably, the long slings used in such procedures are15-30 cm in length and 3-5 cm in width. Shorter slings may be preferredfor procedures in which the sling is suspended by a suture bridge. Suchslings may be 2.5-7 cm in length and 1-5 cm in width.

The optimal dimensions of the sling may also be influenced by the slingmaterial selected. For instance, the thickness of the sling material maybe dependent on the material selected and the strength and tearresistance required for a particular application of the sling.

The dimensions of the preferred embodiment of FIG. 100 are shown inFIGS. 102A and 102B. The approximate dimensions, in inches, are asfollows: A=0.30; B=0.79; C=0.12; D=0.43; F=0.20; G=0.24; H=0.015;I=0.030; and J=0.98. Angle E=22′.

As indicated above, the sling 10B is preferably provided with a visualindicator 20B. The visual indicator enables the surgeon to position thesling relative to the urethra so that the urethra generally extendsacross the center of the sling. In one embodiment, the visual indicator20B comprises two transversely extending dashed lines in the centralportion 12B of the sling 10B as illustrated in FIG. 100. However, thoseskilled in the art will recognize that a variety of other types ofvisual indicators, including radiopaque indicators, could be used inaccordance with the present invention.

The sling of the present invention preferably also has at least onesuture receiving site formed in both the first and second end portionsof the sling. Preferably, the suture receiving site is an aperture. Theaperture may be formed by die stamping the sling material ultrasoniccutting, heat cauterizing, or piercing with a hot poker. Alternatively,the suture receiving site may be sling material as discussed below inregard to FIGS. 104I and 104J.

The suture receiving site is adapted for receiving at least one suture.Preferably, the suture receiving site has an inner diameter at leastequal to the diameter of the suture to be received therein. In thepreferred embodiment depicted in FIG. 100, both the first and second endportions of the sling have two apertures which are equally displacedfrom the central longitudinal axis of the sling. However, numerousalternative embodiments are also contemplated by the present invention.

For example, some embodiments of the sling, such as that depicted inFIG. 103A, have only one suture receiving site formed per end portion.In such embodiments, the suture receiving site 18B is preferably locatedalong the central longitudinal axis 19B of the sling.

Other embodiments of the sling have 3 or more suture receiving sitesformed per end portion. In such embodiments, preferably at least onesuture receiving site 18B is located along the central longitudinal axis19B of the sling with the other suture receiving sites 18B being locatedsymmetrically about the central longitudinal axis 19B as illustrated inFIG. 103C.

Preferably, in embodiments in which the number of suture receiving sitesin each end portion of the sling is odd, at least one suture receivingsite in each end portion of the sling is located along the centrallongitudinal axis of the sling as shown in FIGS. 103A and 103C. In thoseembodiments in which the number of suture receiving sites in each endportion of the sling is even, the suture receiving sites are preferablydisposed symmetrically about the central longitudinal axis of the slingas depicted in FIGS. 100 and 103B.

The use of a plurality of suture receiving sites in each end portion ofthe sling results in reduced buckling of the sling after implantationcompared to embodiments having a single suture receiving site at eachend of the sling. Thus, embodiments having a plurality of suturereceiving sites in each end portion are preferred.

Although several examples of the locations and number of the suturereceiving sites in the end portions of the present slings have beenprovided above, those skilled in the art will appreciate that additionalconfigurations fall within the scope of the present invention. It willalso be appreciated by those skilled in the art that the variousconfigurations and numbers of suture receiving sites described above maybe utilized with any of the sling shapes or biocompatible materialsdescribed above.

FIGS. 104A-104L show various types of suture receiving sites which maybe used in the slings of the present invention. In FIGS. 104A and 104B,the suture receiving site is an aperture formed in the sling material.This type of suture receiving site is employed in the embodiment shownin FIG. 100. Preferably, the material around the periphery of the suturereceiving sites is reinforced by heat sealing or ultrasonic sealing.

In addition, the suture receiving sites can be strengthened in order tominimize the possibility of tearing. For instance, one piece reinforcingdevices may be inserted in the apertures in the sling material. As shownin FIGS. 104C and 104D, the one piece reinforcing device 22B has anupper rim 24B and a lower rim 26B between which the sling materialbordering the suture receiving site is enclosed. Although the upper rimand the lower rim are shown parallel to one another in FIG. 104D,alternative embodiments are contemplated in which the upper and lowerrims converge towards each other with the sling material therebetween.The upper rim and the lower rim may also be provided with frictionenhancing retention structures to minimize the risk of dislodgement ofthe one piece reinforcing device. Preferably, the one piece reinforcingdevice 22B is fabricated from biocompatible plastics or metals, such asstainless steel or titanium.

Alternatively, the area around an aperture 18B in the sling material maybe strengthened by inserting a multiple piece reinforcing device 28Btherein. As illustrated in FIGS. 104E and 104F, the multiple piecereinforcing device 28B has a first piece 30B and a second piece 32B,which interlock and enclose the sling material bordering the suturereceiving site. Although the first piece and the second piece are shownparallel to one another in FIG. 104F, alternative embodiments arecontemplated in which they converge towards each other as discussedabove with respect to the one piece reinforcing device. The first pieceand the second piece may also be provided with friction enhancingretention structures to minimize the risk of dislodgement of themultiple piece reinforcing device. Preferably, the multiple piecereinforcing device 28B is fabricated from biocompatible plastics ormetals, such as stainless steel or titanium.

Yet another way of reducing the risk of tearing comprises reinforcingthe sling material around the periphery of the suture receiving sites.Slings having such reinforced material around the periphery of thesuture receiving site are depicted schematically in FIGS. 104G through104J. In FIGS. 104G and 104H, the suture receiving site is an aperture.In FIGS. 104I and 104J, the suture receiving site comprises slingmaterial. In the embodiment of FIGS. 104I and 104J, the sling materialat the suture receiving site provides a puncture target into which thesurgeon can insert the suspending suture. In FIGS. 104K and 104L thesuture receiving site is an aperture and the periphery of the suturereceiving site is reinforced by heat sealing or ultrasonically sealing.Preferably, the material around the periphery of the suture receivingsites is reinforced by heat sealing or ultrasonic sealing. Thereinforced material 34B around the periphery of the suture receivingsite shown in FIGS. 104G through 104L may be formed in a variety ofways, such as by heat sealing, ultrasonically sealing, or sewing thearea of the sling material along the periphery of the suture receivingsite.

In further embodiments of the present invention, the periphery of thesuture receiving sites is strengthened by making the end portions of thesling thicker than the central portion as shown in FIGS. 105A-1050. Oneway to fabricate slings in which the end portions are thicker than thecentral portion is to fold the end portions of the sling. For example, ahexagonal shaped piece of material, shown in FIG. 105B, may be formed byfolding the parallelogram shaped piece of biocompatible material shownin FIG. 105A along the lines indicated in FIG. 105A. Alternatively, thehexagonal material of FIG. 105B may be formed by folding a trapezoidalpiece of material, as will be apparent to one skilled in the art. Suturereceiving sites may be formed in the hexagonal shaped intermediate ofFIG. 105B to form the hexagonal shaped sling of FIG. 105C, in which theend portions 14B, 16B are generally twice the thickness of the centralportion 12B of the sling. A cross-sectional view of the hexagonal shapedsling depicting the double thickness end portions is shown in FIG. 105D.FIG. 105E illustrates a suture 36B secured in the suture receiving site18B. The suture can be secured to the suture receiving site during themanufacturing process of the sling or by the physician prior to orduring surgery.

In another embodiment, a rectangular piece of material, shown in FIG.105G, may be formed by folding the rectangular piece of biocompatiblematerial shown in FIG. 105F along the lines indicated in FIG. 105F.Suture receiving sites may be formed in the rectangular shapedintermediate of FIG. 105G to form the rectangular sling of FIG. 105H, inwhich the end portions 14B, 16B are generally twice the thickness of thecentral portion 12B of the sling. A cross-sectional view of therectangular shaped sling depicting the double thickness end portions isshown in FIG. 105I. FIG. 105J illustrates a suture 36B secured in thesuture receiving site 18B as discussed above with regard to FIG. 105E.

In a further embodiment, a rhomboid shaped piece of material, shown inFIG. 105L, may be formed by folding the rectangular piece ofbiocompatible material shown in FIG. 105K along the lines indicated inFIG. 105K. Suture receiving sites may be formed in the rhomboid shapedintermediate of FIG. 105L to form the rhomboid shaped sling of FIG.105M, in which the end portions 14B, 16B are generally twice thethickness of the central portion 12B of the sling. A cross-sectionalview of the rhomboid shaped sling depicting the double thickness endportions is shown in FIG. 105N. FIG. 105O illustrates a suture 36Bsecured in the suture receiving site 18B as discussed above with regardto FIGS. 105E and 105J.

Those skilled in the art will appreciate that slings in which the endportions are thicker than the central portion may be made in any of theshapes and configurations disclosed herein and are not limited to theshapes illustrated in FIGS. 105A-1050.

In some embodiments of the present invention, at least one edge 38B,40B, 42B or 44B of each double thickness end portion 14B, 16B is securedto an adjacent layer of the sling either during manufacturing of thesling or by the physician prior to or during the surgical procedure.Alternatively, the sling may be supplied to the surgeon with at leastone edge 38B, 40B, 42B or 44B of each double thickness end portion 14B,16B already secured. Preferably, the edge 38B closest to the centralportion 12B is sewn. More preferably, all edges 38B, 40B, 42B and 44Bare secured. In those embodiments in which the sling is made fromnatural tissue, the edge 42B where the fold was made is preferably notsecured, although the other edges 38B, 40B and/or 44B of the doublethickness end portions may be secured. Numerous methods familiar tothose skilled in the art may be used to secure the edges, such assewing, heat sealing, ultrasonic sealing, stapling or gluing.Preferably, the edges are secured by sewing during the manufacturingprocess or prior to surgery, and by sewing, stapling or gluing duringthe surgical procedure.

As will be apparent to one of skill in the art, slings having endportions that are thicker than the central portion can be made in avariety of ways other than those described above. For example, the slingmaterial may be folded over on itself more than once to produce slingswith end portions more than twice as thick as the central portion.Alternatively, an additional layer or layers of separately cut materialcould be secured to the end portions of the sling, thereby producing asling having end portions of varying thickness. Slings having two ormore layers of material in both the end portions and the central portionare also contemplated. Such slings can be formed by securing the upperlayer or layers of sling material to the lower layer or layers using themethods discussed above.

In addition to the resistance to tearing provided by slings in which thesuture receiving sites are located in end portions that are thicker thanthe central portion, a further benefit is provided by securing the upperlayer of the vertical edge 38B to the lower layer of the sling. Inparticular, the secured vertical edge 38B acts as a reinforcing ribwhich reduces buckling of the sling when the sling is placed undertension after implantation in the patient.

If the suture receiving sites are strengthened using the one piecereinforcement devices, two piece reinforcement devices, or reinforcedmaterial around their periphery as described above, the edges 40B, 42B,44B of the double thickness end portions of the sling may be secured.The vertical edge 38B, however, may be secured to reduce buckling asdescribed above.

Yet a further advantage is provided by forming end portions havingdouble thickness in slings made of directionally oriented materials suchas the materials shown in FIGS. 106A-106G. The directionally orderedfilaments, grains, striations or polymeric chains may be oriented in avariety of directions. For example, FIGS. 106C-106E illustrate enlargedviews of sling materials having longitudinally (FIG. 106C), transversely(FIG. 106D), and diagonally (FIG. 106E) oriented filaments, grains,striations or polymeric chains 46B, all of which are suitable for use inthe present invention. FIG. 106B is a schematic view of grainedmaterials suitable for use with the present invention. Those skilled inthe art will appreciate that the grained materials may have ridges orgrooves therein, or may have a smooth surface. Materials havingmultidirectional filaments, grains, striations or polymeric chains arealso suitable for use in the present invention.

The parallelogram or rhomboid shaped material of FIG. 106A can be foldedalong the indicated lines to form the hexagonal shaped sling havingdouble thickness end portions shown in FIG. 106F as described above withregard to FIGS. 105A-105E. As can be seen in FIGS. 106F and 106G, whenthe directionally oriented material is folded over on itself, thefilaments, grains, striations or polymeric chains in the upper layer ofthe double thickness end portion cross the filaments, grains, striationsor polymeric chains in the lower layer of the end portion. Thisnonparallel orientation of the layers of the material relative to eachother provides additional protection against tearing in the regions ofthe sling surrounding the suture receiving sites by having the strengthof the grain perpendicular to the suture pull direction.

Slings having two or more layers of directionally oriented material inboth the end portions and the central portion, wherein the filaments,grains, striations or polymeric chains in the different layers cross arealso contemplated.

In another embodiment, the slings may have a stabilizer attached to theend portions 14B, 16B to reduce buckling of the sling 10B and to provideadditional strength to the sling 10B, as depicted in FIGS. 108A-108D.Preferably, the stabilizer is made of metal or plastic. The stabilizermay be attached to the sling in a variety of manners such as sewing,heat sealing, mechanical securement, or capturing the stabilizer betweena fold in the sling material. In some embodiments, the stabilizer mayalso be provided with friction enhancing retention structures tominimize the risk of dislodgement of the stabilizer.

In one embodiment, the stabilizer may be attached to an edge at each endof the sling as illustrated in FIGS. 108A and 108B. The stabilizer maycomprise a first side 68B, a second side 70B, and an intermediatesection 72B disposed between the first side 68B and the second side 70B.In this embodiment, the stabilizer preferably contacts both sides of thesling 10B.

In an alternate embodiment, the stabilizer may comprise a single section73B which is disposed between the suture receiving sites 18B and isattached to one side of the sling as illustrated in FIGS. 108C and 108D.

Those skilled in the art will appreciate that additional stabilizerdesigns and locations are possible. For example, a stabilizer which islocated at each end of the sling may contact a single side of the sling10B. In other embodiments, the sling may have one or more stabilizers inthe central portion 12B in addition to the stabilizers in the endportions 14B, 16B. In addition, those skilled in the art will appreciatethat the stabilizers may be used in conjunction with any of the slingembodiments described herein.

As previously discussed, the slings can be supplied to the surgeon withthe sutures preattached or the sutures can be attached to the suturereceiving sites by the surgeon. In either case, a variety of sutureattachment methods are contemplated by the present invention.

For example, FIG. 107A shows an enlarged top view of an end portion of asling having two suture receiving sites 18B with a suture 36B securedthereto. In this embodiment, the suture 36B is looped through the suturereceiving sites 18B, as illustrated in the cross-sectional view of FIG.107B. Alternatively, the suture can be threaded through one suturereceiving site and out the other suture receiving site without loopingthrough the sling material therebetween.

Alternatively, the suture 36B can be threaded through a single suturereceiving site 18B as illustrated in FIGS. 107C and 107D.

Another method of attaching the suture to the sling is illustrated inFIGS. 107E and 107F. In accordance with this method, the suture 36B islooped around the suture receiving site 18B and the edge of the sling.

While FIGS. 107A-107E show a variety of methods for attaching the sutureto the sling, those skilled in the art will appreciate that othermethods may also be used. Yet another method of attaching the suture 36Butilizes a connector to link the suture to the sling. Suitableconnectors for linking the suture to the sling are disclosed in U.S.patent application Ser. No. 09/023,533, entitled “Method and Apparatusfor Minimally Invasive Pelvic Surgery,” (VESITEC. 028A) filed Feb. 13,1998, now issued U.S. Pat. No. 6,099,547, issued Aug. 8, 2000, and theidentically titled U.S. Provisional Patent Application Ser. No.60/038,380 filed Feb. 13, 1997, the disclosures of which areincorporated herein by reference. In such embodiments, the sling has aring member therein to permit the connector to be attached to the sling.Ring members suitable for attaching the connector are also disclosed inthe above incorporated U.S. patent application Ser. No. 09/023,533,entitled “Method and Apparatus for Minimally Invasive Pelvic Surgery,”(VESITEC. 028A) filed Feb. 13, 1998, now issued U.S. Pat. No. 6,099,547,issued Aug. 8, 2000, and the identically titled U.S. Provisional PatentApplication Ser. No. 60/038,380 filed Feb. 13, 1997.

Those skilled in the art will appreciate that a variety of other sutureattachment methods can be used in accordance with the present invention.

The present invention also includes prefabricated slings having integralattachment members 148B. Such slings can be die cut or ultrasonicallycut out of a solid sheet of biocompatible material. Preferably, theslings having integral attachment members are cut from one length ofmaterial and the edges are heat sealed. Alternatively, the integralattachment members may comprise trailing filaments such as longerstrands in a woven sling. In a further embodiment, the integralattachment members comprise filaments interwoven through the slingmaterial. The function of the integral attachment members 148B issimilar to that of the sutures 36B, which allow the surgeon to suspendthe sling from a structure, such as the pubic bone as described in moredetail below.

Representative examples of slings having integral attachment members aredepicted in FIGS. 109A and 109B. FIG. 109A shows a generally rectangularshaped sling 110B in which bilaterally extending integral attachmentmembers 148B are formed from the same piece of material as the sling.FIG. 109B shows a generally hexagonal shaped sling 110B in whichbilaterally extending integral attachment members 148B are formed fromthe same piece of material as the sling. Those skilled in the art willappreciate that slings with integral attachment members havingconfigurations other than those shown in FIGS. 109A and 109B are alsocontemplated by the present invention.

The slings of the present invention may be individually packaged and/orsterilized prior to purchase. The packaging may protect the sling duringstorage. For example, in embodiments in which the sling materialcomprises a collagen coated filamentous material, the packaging mayprotect the sling from damage by ultraviolet light. The sling may besoaked in an antibiotic solution, such as a solution of neomycin,bacitracin, or polymixim, to prevent microorganisms from collecting onand colonizing the surface of the sling during manipulation, therebyreducing the risk of infection following implantation of the sling. Thesling may also be sterilized by ethylene oxide or irradiation. Uptakeand delivery of the antibiotic may be enhanced by using a coated slingas described above.

In embodiments in which the sling is made of natural tissue, the slingmay be stored in glutaraldehyde or freeze dried. Prior to use in thesurgical procedure, the natural tissue may be preconditioned by soakingthe sling in a saline solution, such as any standard commerciallyavailable saline solution.

The present invention also includes a stabilization sling kit formaintaining urinary continence. Preferably, the kit comprises aprepackaged sling. More preferably, the kit comprises a sterilizedsling. In one embodiment, the kit includes a sling having suturessecured thereto. Alternatively, the sling included in the kit may haveintegral attachment members as described above.

A minimally invasive percutaneous method of sling delivery andstabilization to treat an incontinent patient will now be described withreference to FIGS. 110-113. Preoperatively, the patient receives broadspectrum antibiotics, such as gentamicin and ampicillin. The patient isplaced in the dorsal lithotomy position and regional or generalanesthesia is administered. Preparation of the Patient EmphasizesIsolation of the Anus with a Stapled Towel or Plastic Drape. A Foleycatheter is placed.

An approximately 1-2 centimeter midline incision 52B is made in theupper vaginal wall 54B beneath the bladderneck, such as at theurethro-vesical junction, as illustrated in FIG. 111. The surgeon theninserts an instrument such as surgical scissors through the incision inthe upper vaginal wall and bluntly dissects the tissue 58B on both sidesof the urethra 56B to create a bilaterally extending pocket 60B, whichis illustrated in FIG. 112.

No. 09/023,533, entitled “Method and Apparatus for Minimally InvasivePelvic Surgery,” (VESITEC. 028A) filed Feb. 13, 1998, now issued U.S.Pat. No. 6,099,547, issued Aug. 8, 2000,

The bilaterally extending pocket can also be created and the sling canbe inserted using a variety of other minimally invasiveinstruments/methods including the transvaginal, hiatal and percutaneousapproaches disclosed in U.S. patent application entitled “TransvaginalAnchor Implantation Device,” Ser. No. 08/744,439, filed Nov. 8, 1996,now issued U.S. Pat. No. 6,053,935, issued Apr. 25, 2000; U.S. patentapplication Ser. No. 09/023,965, entitled “Percutaneous and HiatalDevices and Methods for Use in Minimally Invasive Pelvic Surgery”(VESITEC.029A), filed Feb. 13, 1998, now issued U.S. Pat. No. 6,423,080,issued on Jul. 23, 2002; U.S. Provisional Patent Application entitled“Percutaneous and Hiatal Devices and Methods for Use in MinimallyInvasive Pelvic Surgery,” Ser. No. 60/038,171, filed Feb. 13, 1997; U.S.patent application Ser. No. 09/023,533, entitled “Method and Apparatusfor Minimally Invasive Pelvic Surgery” (VESITEC.028A) filed Feb. 13,1998, now issued U.S. Pat. No. 6,099,547, issued Aug. 8, 2000; and U.S.Provisional Patent Application entitled “Method and Apparatus forMinimally Invasive Pelvic Surgery,” Ser. No. 60/038,380, filed Feb. 13,1997, the disclosures of which are incorporated herein by reference. Forexample, these other approaches may be employed when the physiciandesires to attach a long strip of material to the pubic bone or otherstructures such as the abdominal musculature with a bone anchor or othersecuring device. In such approaches, an opening capable of accommodatingthe long strip of material is created in the body tissue, the sling isintroduced into the opening in the body tissue, and the sling isattached directly or indirectly to the pubic bone or other structuressuch as the abdominal musculature. Either before or after creating thepocket 60B, a bone anchor 62B, such as a screw in anchor, a push inanchor, or a punch in anchor, is introduced into the pubic bone 64B forfixation of suspensory sutures, with or without pre-drilling a hole inthe pubic bone. For instance, the bone anchor is introduced using a boneanchor implantation device of a type such as that illustrated in FIGS.15-19 of U.S. application Ser. No. 08/385,897, filed Feb. 9, 1995, nowissued U.S. Pat. No. 5,766,221, issued Jun. 16, 1998, which is herebyincorporated herein by reference. Bone anchor sites are located byplacing the bone anchor implantation device on the body over the area ofthe pubic bone after visualization or digital palpation over the bone.The surgeon then extends the bone probes distally until both probes havemade contact with the pubic bone. Preferably, one anchor 62B for eachside (two per patient) is implanted into the tubercle portions of thepubic bone 64B (approximately two centimeters lateral to the symphysispubis). Preferably, the eyelet of the anchor is recessed below thesurface of the bone or flush with the surface of the bone. The anchor62B preferably has a suture 36B slidably secured thereto prior toimplantation of the anchor into the pubic bone so that a first sutureend and a second suture end extend from the implanted anchor afterremoval of the anchor driver.

Two separated approximately one inch transverse incisions are made overthe pubic bone as illustrated in U.S. Pat. No. 5,611,515, issued Mar.18, 1997 to Benderev et al., the disclosure of which is incorporatedherein by reference, and dissection is carried down to the area of therectus fascia. The first end of the anchored suture is manually placedinto a suture channel of a suture passer of a type such as thatillustrated in FIGS. 45 and 45 a of the above incorporated U.S. Pat. No.5,611,515, issued Mar. 18, 1997 to Benderev et al. The probe is moveddistally to lock the suture therein.

Beginning on the right side, the suprapubic wound is stretched cephaladto allow the vertical passage of the suture passer through the rectusfascia with the probe tip fully exposed. Distal advancement of thesuture passer is accomplished with the tip proximally retracted withinthe probe guide. The suture passer is acutely angled into the abdomen sothat the point rests on the underside of the pubic periosteum.

While maintaining contact with the underside of the pubis, the suturepasser with the probe tip retracted is thereafter passed distally towardthe introitus. At the completion of this distal passage, the suturepasser can be palpated through the introitus to the right of the urethra56B. The distal end tip of the suture passer is withdrawn from thesurface of the pubourethral ligament and gently swept along thepubocervical fascia to the area of the bladder neck under the guidanceof a finger within the vagina. Palpation through the vagina may besafely performed to assist in localization of the suture passer tip.

The probe tip is then distally extended. The suture passer is thenpassed through the endopelvic fascia and into the pocket 60B between theurethra 56B and the upper vaginal wall 54B at which time the probe tipis retracted. The surgeon then guides the suture passer distally intothe vagina through the midline incision 52B in the upper vaginal wall54B. The probe is then retracted maximally to the unlocked position toallow the first end of the suture to be manually removed from the suturechannel.

The surgeon selects a sling, such as sling 10B of the present invention.The surgeon secures the suture 36B to a first end portion 14B of thesling by advancing the first end of the suture through the suturereceiving site 18B as previously described.

After securing the suture 36B to the first end portion of the sling 10B,the first end of the suture is placed into the unlocked suture channeland locked into place. The suture passer and suture locked therein arethen pulled up through the suprapubic wound. The first end of the sutureis then released from the suture channel by manually retracting theprobe.

The identical procedure is performed on the left side.

The surgeon places the sling 10B into the pocket 60B through the midlineincision 52B in the upper vaginal wall 54B. The sling is placed underthe urethra, preferably under the bladderneck, in order to realign theurethra and bladderneck to the correct anatomical position and provide astable floor to counteract internal stresses.

As will be apparent to one of skill in the art, the sling may be placedbeneath the bladderneck in a variety of ways other than via the pocket60B. For instance, an inverted U shaped incision may alternatively bemade beneath the bladderneck. The tissue beneath the inverted U shapedincision may be bluntly dissected to create a flap. The sling may thenbe inserted in the dissected opening.

After placing the sling in the pocket or opening, the surgeon aligns thesling so that the visual indicator 20B is located directly beneath theurethra 56B. As will be apparent to one of skill in the art, alignmentof the sling relative to the urethra can be accomplished in a variety ofways, such as by direct visualization.

After the sling 10B is correctly positioned, the first and second endsof the suture on each side are tied to each other with sufficienttension to stabilize and support the bladder neck as illustrated inFIGS. 110 and 113. The Foley catheter is removed prior to tying thesuspensory sutures.

In order to minimize postoperative urinary blockage caused by excessivetension, and minimize postoperative urinary incontinence due toinsufficient tension, suture tension is regulated by tying the first andsecond ends of the sutures across a suture tensioner of a type such asthat illustrated in FIGS. 46-49 of the above incorporated U.S. patentapplication entitled “Bladder Neck Suspension Procedure”, Ser. No.08/042,739, filed Apr. 5, 1993, now issued U.S. Pat. No. 5,611,515,issued Mar. 18, 1997. The suture tensioner is thereafter removed and theposition of the visual indicator 20B relative to the urethra isreconfirmed prior to closing the vaginal and suprapubic wounds.

The wounds are irrigated with an antibiotic solution, such as abacitracin solution. The wound edges and the rectus fascia at the sutureentry points are infiltrated with bupivacaine. A Foley catheter isintroduced. Alternatively, a suprapubic tube can be placed, especiallyin those patients having dexterity problems or an aversion to learningintermittent catheterization.

Following surgery, the patient is given either ciprofloxacin orofloxacin for ten days. For those patients having a Foley catheter, thecatheter is removed approximately one week following surgery. Thepatient performs intermittent catheterization as necessary until thepost-void residuals are less than 75 cc on two consecutivecatheterizations. In patients having a suprapubic tube, the suprapubictube is removed when the post-void residuals are less than 75 ccfollowing two consecutive urinations.

As will be apparent to one of skill in the art, the foregoing method canbe readily modified for use with sling 110B in which the function of theintegral attachment members 148B is similar to that of the sutures 36Bdescribed above. In addition, while the foregoing procedure wasdescribed using two bone anchors per patient, one of ordinary skill inthe art will recognize that the procedure could also be accomplishedusing either one anchor per patient or greater than two anchors perpatient. The one anchor embodiment is especially preferred for use withslings having a single suture end or single integral attachment memberextending from each end of the sling, such as the sling 110B illustratedin FIG. 109B. In those cases where one anchor per patient is used, theanchor is preferably located adjacent to the symphysis pubis. The slingsof the present invention can also be suspended from structures otherthan bone, such as Cooper's ligament or the rectus fascia without usingbone anchors.

Although this invention has been described in terms of certain preferredembodiments, other embodiments which will be apparent to those ofordinary skill in the art in view of the disclosure herein are alsowithin the scope of this invention. Accordingly, the scope of theinvention is intended to be defined only by reference to the appendedclaims.

1. (canceled)
 2. A system for treating urinary incontinence, comprisinga urethral support sling including a bioabsorbable coating.
 3. Thesystem of claim 2, wherein the sling has a substantially flat shape. 4.The system of claim 2, wherein the sling has one or more pores orinterstices.
 5. The system of claim 4, wherein the coating blocks one ormore of the pores or interstices.
 6. The system of claim 2, wherein thecoating facilitates tissue ingrowth into the sling.
 7. The system ofclaim 2, wherein the coating includes one or more drugs.
 8. The systemof claim 7, wherein the one or more drugs are antibiotics, heparin, orimmunosuppressant agents.
 9. The system of claim 2, wherein the coatingis collagenous.
 10. The system of claim 9, wherein the coating is asmooth layer of collagen.
 11. The system of claim 2, wherein the coatingis polyglycolic acid, polylactic acid, blends of polyglycolic acid andpolylactic acid, gelatin, polyvinyl alcohol, polyvinyl pyrrolidone, orcombinations thereof.
 12. The system of claim 2, further comprising apouch for covering only partially, the sling.
 13. The system of claim 2,further comprising a shaft having a curved portion.
 14. A system fortreating urinary incontinence comprising, a shaft having a curvedportion and a distal end; and a sling assembly, comprising: a urethralsupport sling including a bioabsorbable coating, and an end capable ofassociating with the distal end of the shaft.
 15. The system of claim14, wherein the sling assembly further comprises a pouch that covers thesling only partially.
 16. The system of claim 15, wherein the sling isshorter in length than the pouch.
 17. The system of claim 15, wherein atleast one end of the pouch is open.
 18. The system of claim 15, whereinthe pouch has a flat shape.
 19. The system of claim 15, wherein thepouch is relatively flexible.
 20. A method for treating female urinaryincontinence comprising: providing a urethral support sling including abioabsorbable coating, and placing at least a portion of the sling undera urethra of a patient to treat female urinary incontinence.